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.
