Lead Medical Project Coord

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Lead Medical Project Coordinator

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 Lead Medical Project Coordinator leads the management, coordination and evaluation of 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 proactively liaises with clients to ensure optimal performance and utilization of medical project team(s).

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:

• 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.

Apply today to help us deliver tomorrow’s breakthroughs.