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 enabling customers to make the world healthier, cleaner, and safer. We provide resources for career growth and advance science through research, development, and delivery of life-changing therapies. With clinical trials in over 100 countries and innovative clinical research frameworks through our PPD clinical research portfolio, we offer laboratory, digital, and decentralized clinical trial services. Your dedication to quality and accuracy will improve health outcomes for individuals and communities. We have a proven track record, having supported the top 50 pharmaceutical companies and over 750 biotechs, managing 2,700 clinical trials across 100+ countries in 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

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.
Works independently to perform 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 and resolves or escalates potential issues.
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 and can act as the alliance level lead on larger alliance/multi-protocol studies.
Creates and maintains medical management plans on studies, ensuring processes align with contracts and requested services for studies with departmental involvement and standalone studies (e.g., MM and/or MPC).
Works independently to monitor 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.
Independently determines hours required for out-of-scope work and provides this to finance/study teams for contract modifications. Attends meetings to discuss/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.