Lead Medical Project Coordinator

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.