Sr Medical Project Coordinator

Thermo Fisher Scientific • Morrisville, NC

1d • Onsite

About The Position

Join Thermo Fisher Scientific as a Senior Medical Project Coordinator and contribute to meaningful work that impacts global health. Our mission is to enable customers to make the world healthier, cleaner, and safer. We provide resources for career growth and support scientific advancement through research, development, and delivery of life-changing therapies. With a strong presence in clinical trials across 100+ countries and innovative clinical research frameworks, we offer laboratory, digital, and decentralized trial services. Your dedication to quality and accuracy will enhance health outcomes for individuals and communities.

We have a proven track record, having supported the top 50 pharmaceutical companies and over 750 biotechs, contributing to 2,700 clinical trials in more than 100 countries over the last five years.

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)
• 5+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
• 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

Nice To Haves

• 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.

Responsibilities

• Manages, coordinates, and evaluates medical projects for one or more programs in collaboration with management and stakeholders to ensure consistency, alignment, and compliance of internal processes, optimal performance, and issue resolution throughout the project lifecycle.
• Represents the company in the medical research community and develops collaborative relationships with client company personnel.
• Performs first pass review of safety data using line listings, company dashboards, and/or other visualization tools.
• Reviews data for safety trends, coding consistencies, and potential follow-up with investigator sites.
• Proactively identifies potential issues and resolves or escalates them as appropriate.
• Reviews safety data and provides summations for safety review meetings.
• Reviews designated sections of aggregate reports.
• Independently functions as the Project Lead for medical monitoring services when SAE case processing has not been contracted.
• Manages project implementation, coordination, maintenance, and close-out of assigned studies.
• Serves 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.
• Creates and maintains medical management plan(s) on studies, ensuring processes reflect the contract and services requested for studies with department involvement and standalone studies (e.g., MM and/or MPC).
• Monitors project financial status, unit forecasting, actual realization, and team allocations.
• Coordinates staff projections based on contract values and actual hours used.
• Escalates financial and/or operational risks and attends risk management meetings.
• Determines hours required for out-of-scope work and provides this information for contract modifications.
• Attends meetings to discuss and justify modification requirements.
• Resolves complex problems through in-depth evaluation and offers solutions.
• May assist management in training and mentoring.
• Presents at business development, client, and investigator meetings and participates in strategy/business development calls.
• Represents studies at risk management meetings.

Benefits

• Resources needed to achieve individual career goals
• Support for scientific advancement through research, development and delivery of life-changing therapies

What This Job Offers

• Job Type: Full-time
• Career Level: Senior