19 empleos en ThermoFisher Scientific

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
What You'll Do:
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Lead Medical Project Coordinator**
At Thermo Fisher Scientific, your work will have a meaningful impact on global health. By supporting clinical research, you'll help advance life-changing therapies while growing your career in a collaborative and innovative environment.
As a Lead Medical Project Coordinator, you'll lead the coordination and oversight of medical projects, working closely with cross-functional teams and clients to ensure high-quality delivery, effective collaboration, and successful project execution throughout the study lifecycle.
**What You'll Do:**
- Work independently to perform and/or lead first pass review of safety data
utilizing line listings, company dashboard(s), and/or other visualization tools.
- Review data for safety trends, coding consistencies, and potential follow up
with investigator sites. Proactively identify any potential issues and resolve or
escalate as appropriate.
- Review safety data and provide comprehensive summations for safety review
meetings. Review designated sections of aggregate reports.
- Initiate and lead initiatives to improve current processes and develops new
processes regarding medical monitoring and department services. May develop
guidance documents and assist with the implementation and/or revision of
corporate level documents such as SOP's and WPD's.
- Independently function as the Project Lead for medical monitoring services
when SAE case processing has not been contracted. Manage project
implementation, coordination, maintenance and close out of assigned studies as
applicable. Serve as the primary point of contact for clinical project teams on
studies and can act as the alliance level lead on larger alliance/multi-protocol
studies.
- Create and maintain safety and medical management plan(s) on studies (as
applicable) and ensure that the processes included in the plan document are
reflective of the contract and service requested for studies that have
department involvement as well as standalone studies (ex. MM and/or MPC).
- Work independently to monitor the project financial status, unit forecasting,
actual realization, and team allocations in systems. Coordinate staff
projections based on contract values and actual hours used. Escalate any
financial and/or operational risks and can attend risk management meetings to
discuss.
- Present at business development, client, and investigator meetings and
participate in strategy/business development calls. Represent studies at risk
management meetings.
- Independently determine hours required for out of scope work for both the MM
and MPC and provides this to the finance/study team for contract modifications.
Attend meetings to discuss/justify the modification requirements.
- Train and develop new team members. Serve as main point of contact for
team member questions with escalation to management as appropriate. May
provide input on individual performance to direct line manager. Organize and
lead meetings with team members to discuss potential process issues, answer
questions, and brainstorm ideas and solutions.
- Resolve complex problems through in-depth evaluation of various factors and
offers solutions.
**Education and Experience Requirements:**
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years), to include 8+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
**Knowledge, Skills, Abilities:**
- Superior knowledge of GCPs for medical oversight of clinical trials
- Advanced knowledge of drug development and safety reporting
- Extensive knowledge of safety data trending to include coding
- Good knowledge of biostatistics, data management and clinical procedures
- Exceptional problem solving and critical thinking skills
- Exceptional project management and budget skills
- Excellent mentoring skills and ability to train and lead others
- Exceptional oral and written communication skills
- Detail-oriented mindset
- Able to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**Working Environment:**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves
**Why join us?**
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join us as **Medical Project Coordinator** - And utilize your expertise to support and enhance drug safety operations, ensuring compliance with regulatory standards and optimal patient safety in clinical trials.
**What You'll Do:**
- Coordinate and review safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Review data for safety trends,
coding consistencies, and potential follow up with investigator sites. Identify potential issues and resolve or escalate as appropriate.
- Review safety data and may provide summations for safety review meetings.
- May review designated sections of aggregate reports.
- May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested.
- May help manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations.
- Monitor the status of the data review and escalate any delays and/or risks to all stakeholders, including study leads.
- May present at business development, client, and investigator meetings and participate in strategy/business development calls.
- Resolve complex problems through in-depth evaluation of various factors and offers solutions.
- May serve as the primary point of contact for clinical/data management project teams.
- May assist management in training and mentoring.
**Education and Experience:**
- Bachelor's degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
- Knowledge of GCPs for medical oversight of clinical trials and SAE processing
- Knowledge of drug development and safety reporting
- Knowledge of safety data trending to include coding
- Working knowledge of biostatistics, data management and clinical procedures
- Strong problem solving and critical thinking skills
- Good oral and written communication skills
- Good attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**Working Conditions and Environment:**
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.
**Physical Requirements:**
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.
- Regular and consistent attendance.
**Why Join Us?**
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthrough.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Senior Medical Project Coordinator**
At Thermo Fisher Scientific, you'll do meaningful work that makes a positive impact on global health. You'll be part of a global organization supporting leading pharmaceutical and biotechnology companies while contributing to the development of life-changing therapies. Through collaboration, innovation, and continuous learning, you'll have the opportunity to grow your career while helping advance clinical research worldwide.
**What You'll Do:**
The Senior Medical Project Coordinator manages, coordinates and evaluates medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel.
- Work independently to perform first pass review of safety data, utilizing line
listings, company dashboard(s) and/or other visualization tools. Review data for
safety trends, coding consistencies, and potential follow up with investigator
sites. Proactively identify any potential issues and resolve or escalate as
appropriate.
- Review safety data and provide summations for safety review meetings.
Review designated sections of aggregate reports.
- Independently function as the Project Lead for medical monitoring services
when SAE case processing has not been contracted. Manage project
implementation, coordination, maintenance and close out of assigned studies as
applicable. Serve as the primary point of contact for clinical project teams on
studies and can act as the alliance level lead on larger alliance/multi-protocol
studies.
- Create and maintain medical management plan(s) on studies (as applicable)
and ensure that the processes included in the plan document are reflective of
the contract and services requested for studies that have department
involvement and those that are standalone studies (ex. MM and/or MPC).
- Work independently to monitor the project financial status, unit forecasting,
actual realization, and team allocations in systems. Coordinate staff projections
based on contract values and actual hours used. Escalate any financial and/or
operational risks and can attend risk management meetings to discuss.
- Independently determine hours required for out of scope work for the teams
and provide this to the finance/study team for contract modifications. Attend
meetings to discuss/justify the modification requirements.
- Resolve complex problems through in-depth evaluation of various factors and
offers solutions. May assist management in training and mentoring.
- Present at business development, client, and investigator meetings and
participates in strategy/business development calls. Represent studies at risk
management meetings.
**Education and Experience Requirements:**
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
5+ years), to include 5+ years clinical safety experience (clinical research monitoring, or
pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
**Knowledge, Skills, Abilities:**
- Advanced knowledge of GCPs for medical oversight of clinical trials
- Knowledge of drug development and safety reporting
- Advanced knowledge of safety data trending to include coding
- Working knowledge of biostatistics, data management and clinical procedures
- Excellent problem solving and critical thinking skills
- Excellent project management and budget skills
- Effective mentoring skills and ability to train and lead others
- Strong oral and written communication skills
- Strong attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**Working Environment:**
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations, frequent travels both domestic and international.
**Why join us?**
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
As a Senior Manager of PPI Business System at Thermo Fisher Scientific, you will facilitate transformational change and continuous improvement across the organization. Leading the implementation of our Practical Process Improvement (PPI) Business System, you will partner with business leaders to establish and mature lean management practices that enable profitable growth, enhance customer experience, and increase employee engagement. Through strategic deployment, coaching, and hands-on facilitation of improvement initiatives, you will help develop a problem-solving culture focused on operational excellence. You'll collaborate with cross-functional teams to streamline processes, eliminate waste, and deliver measurable results in quality, productivity, and customer satisfaction.
REQUIREMENTS:
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in lean leadership implementing continuous improvement initiatives
- Preferred Fields of Study: Engineering, Science, Business, Operations or related field
- Six Sigma Black Belt and/or Lean certification preferred
- Project Management Professional (PMP) certification a plus
- Demonstrated experience developing and deploying PPI/lean tools including:
- Strategy deployment and value stream mapping
- Tiered daily management systems and leader standard work
- Kaizen facilitation and problem-solving methodologies
- Standard work, error-proofing, and visual management
- Strong financial and business acumen with ability to identify, quantify and track improvement opportunities
- Excellent communication, presentation and influence skills to engage all organizational levels
- Demonstrated success coaching and developing continuous improvement capabilities in others
- Experience leading change initiatives in a matrix organization
- Strong project management skills and ability to manage multiple priorities
- Ability to travel up to 30%
- Manufacturing/operations experience preferred
- Expertise in data analytics and performance metrics
- Proficiency in Microsoft Office suite required
- Commitment to driving improvement and leading transformational change
- Ability to work effectively across functions without direct authority
- Experience in regulated industry (e.g., life sciences, medical devices) preferred
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Clinical Research Associate (CRA / Sr. CRA)**
**At Thermo Fisher Scientific, our Clinical Research team supports leading pharmaceutical, biotechnology, and emerging biopharma companies in advancing innovative therapies worldwide. Having contributed to thousands of clinical trials across more than 100 countries, we are committed to accelerating research that improves patient lives.**
**As a Clinical Research Associate (CRA), you will play a key role in the monitoring and management of clinical trial sites, ensuring compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures. Working closely with investigative sites and cross-functional teams, you will help safeguard patient safety, data integrity, and overall study quality while supporting the successful delivery of clinical research programs.**
**Position Summary**
**As a Clinical Research Associate (CRA), you will be responsible for performing and coordinating clinical monitoring and site management activities across clinical trials. You will conduct remote and on-site monitoring visits, ensure compliance with study protocols, ICH-GCP guidelines, applicable regulations, and SOPs, while safeguarding subject safety, data integrity, and audit readiness. You will collaborate closely with investigational sites, sponsors, and cross-functional project teams to support the successful execution of clinical studies.**
**Key Responsibilities:**
**Conduct on-site and remote monitoring visits using a risk-based monitoring approach.**
**Review source documentation, case report forms (CRFs), and study data to ensure accuracy, completeness, and compliance.**
**Perform site management activities, including site initiation, routine monitoring, and close-out visits.**
**Assess investigational product accountability through inventory and records review.**
**Identify site process issues, perform root cause analysis, and support implementation of corrective and preventive actions.**
**Ensure essential documents are maintained in accordance with ICH-GCP and regulatory requirements.**
**Prepare monitoring reports, follow-up letters, and study documentation within established timelines.**
**Maintain effective communication with investigational sites, sponsors, and internal study teams.**
**Support site identification, feasibility, and investigator engagement activities when applicable.**
**Track study progress and maintain accurate records in clinical trial management systems (CTMS) and other study tools.**
**Support regulatory inspections, audits, and quality initiatives.**
**Contribute to process improvements, project deliverables, and knowledge sharing across teams.**
**Minimum Qualifications:**
**Bachelor's degree in Life Sciences, Nursing, or a related healthcare field, or an equivalent combination of education and experience.**
**Valid driver's license, where applicable.**
**Ability to travel as required.**
**Experience:**
**Relevant clinical research and/or clinical monitoring experience in a pharmaceutical, biotechnology, CRO, or healthcare environment.**
**Candidates may be considered for CRA or Sr CRA opportunities based on their experience, qualifications, and demonstrated monitoring expertise.**
**Preferred Skills & Competencies:**
**Knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulations.**
**Understanding of medical terminology and therapeutic areas.**
**Strong critical thinking, problem-solving, and root cause analysis skills.**
**Experience with Risk-Based Monitoring (RBM) methodologies.**
**Excellent organizational and time management skills.**
**Strong written and verbal communication skills, including professional interaction with investigators and site personnel.**
**Ability to work independently and collaboratively in a global team environment.**
**Proficiency with Microsoft Office and clinical trial systems.**
**Strong attention to detail and commitment to quality.**
**English proficiency required.**
**Working Conditions and Environment**
**- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.**
**- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.**
**- Exposure to biological fluids with potential exposure to infectious organisms.**
**- Personal protective equipment required such as protective eyewear, garments and gloves.**
**- Exposure to fluctuating and/or extreme temperatures on rare occasions.**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Senior Project Manager Clinical Supplies- Make an Impact at the Forefront of Innovation
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
The Senior Project Manager Clinical Supplies manages full supply chain oversight for high complex global clinical trials. Ensures project/study activities are in compliance with company and client requirements. Mentors and provides on-going support to junior team members. Acts as a department representative on all assigned projects and provides consultation services to clients.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
What You'll Do:
- Develop study-specific plans for each assigned project.
- Meet with internal teams to coordinate efforts, provide recommendations and assess risks, and update project reports and spreadsheets.
- Ensure fluent communication and interaction between internal departments in order to avoid obstacles during the course of the study.
- Integrate all clinical supplies activities into the supply chain to support project logistic strategy and compliance with GxP requirements.
- Participate in ongoing training on new regulations.
Education and Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills, Abilities:
- Excellent English and communication skills both written and verbal
- Excellent interpersonal, planning, organizational, problem solving, sense of urgency and decision
making skills.
- Demonstrated leadership and team building skills
- Strong working knowledge of Microsoft Office suite
- In-depth focus on customers and attention to detail
- Ability to work in team environment, as well as work completely independent
- Comprehensive understanding of clinical supply operation
- Strong client building and 3rd party relationship management
- Outstanding ability to provide customer service with the highest standards of quality and excellence
- Skillful in bid preparation and bid defense
Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Work may be performed in a production, office or home-based environment with exposure to
electrical office equipment.
- Occasionally travels both domestic and international
Why join us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Sr Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
**The therapeutic scope includes Cardiovascular & Internal Medicine-** Nephrology, Dermatology, GI, (UC/CD, EOE, EE), Cardiovascular, Liver, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell and Gene Therapy, CAR-T in Autoimmune.
**Nephrology:** (CKD, Delayed Graft Function, Antibody-Mediated Rejection, IgA Nephropathy, Lupus Nephritis)
**Dermatology:** Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa (HS), Prurigo Nodularis, Rosacea, Vitiligo, Alopecia Areata
What You'll Do:
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Clinical Trial Manager**
**Make an Impact at the Forefront of Innovation**
**At Thermo Fisher Scientific, our Clinical Research team supports leading pharmaceutical, biotechnology, and emerging biopharma companies in advancing innovative therapies worldwide. Having contributed to thousands of clinical trials across more than 100 countries, we are committed to accelerating research that improves patient lives.**
**As a Clinical Trial Manager (CTM), you will play a critical role in leading the operational delivery of clinical studies, ensuring quality, compliance, and execution excellence. Working closely with sponsors, investigative sites, and cross-functional teams, you will help drive clinical programs from study start-up through closeout while maintaining a strong focus on timelines, patient safety, data integrity, and business objectives.**
**Position Summary**
**The Clinical Trial Manager (CTM) is responsible for overseeing the clinical operational and quality aspects of assigned studies, ensuring delivery of clinical milestones and final study deliverables within agreed timelines, budget, and quality expectations. This role provides leadership to cross-functional clinical teams, manages study performance metrics, supports resource planning, and ensures compliance with ICH-GCP, applicable regulations, and company procedures. Depending on project requirements, the CTM may also assume Clinical Study Manager (CSM) or Clinical Lead responsibilities.**
**Key Responsibilities:**
**Lead and manage clinical operational activities for assigned studies from start-up through study closeout.**
**Ensure studies are conducted in compliance with ICH-GCP, regulatory requirements, sponsor expectations, and company procedures.**
**Develop and maintain key clinical study documents, including Monitoring Plans, Monitoring Guidelines, and other study-specific tools.**
**Contribute to the development and execution of study management plans and clinical deliverables.**
**Oversee Trial Master File (TMF) quality, completeness, and inspection readiness.**
**Collaborate with project managers, sponsors, CRAs, start-up teams, and cross-functional stakeholders to ensure study objectives are achieved.**
**Lead clinical team meetings and provide guidance, oversight, and support to study team members.**
**Monitor study timelines, performance metrics, risks, and issue resolution activities.**
**Review monitoring reports, study progress, query management, and overall site performance.**
**Support study start-up activities, including ethics committee and regulatory submissions, where applicable.**
**Manage clinical resources, workload distribution, and identification of additional resource needs.**
**Provide project updates and operational insights to internal stakeholders and clients.**
**Support financial oversight through resource planning, forecasting, and budget awareness.**
**Participate in client meetings, hand-off meetings, bid defense activities, and other sponsor-facing interactions as required.**
**Drive continuous process improvement initiatives and promote operational excellence across clinical programs.**
**Minimum Qualifications:**
**Bachelor's degree in Life Sciences, Nursing, Healthcare, or a related scientific field, or an equivalent combination of education and experience.**
**Ability to travel as required for business and study-related activities.**
**Experience:**
**Relevant experience in clinical research, clinical operations, study management, or clinical trial leadership within a pharmaceutical, biotechnology, CRO, or healthcare environment.**
**Candidates may be considered for CTM, Sr. CTM, or Clinical Lead opportunities based on their experience, qualifications, leadership capabilities, and demonstrated expertise in clinical trial management.**
**Preferred Skills & Competencies:**
**Strong knowledge of clinical trial operations, monitoring processes, and study management principles.**
**Solid understanding of ICH-GCP guidelines, FDA regulations, and other applicable global regulatory requirements.**
**Demonstrated leadership, mentoring, and team management skills.**
**Strong project planning, prioritization, and organizational capabilities.**
**Excellent problem-solving, critical thinking, and decision-making skills.**
**Experience managing study timelines, resources, budgets, and performance metrics.**
**Strong interpersonal and stakeholder management skills in a global matrix environment.**
**Effective written and verbal communication skills, including English proficiency.**
**Ability to work successfully in a fast-paced and evolving clinical research environment.**
**Proficiency with Microsoft Office and clinical trial management systems.**
**Strong attention to detail and commitment to quality.**
**Working Conditions and Environment**
Work is performed in an office environment with exposure to electrical office equipment.
Frequently drives to site locations and frequently travels both domestic and international.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.