Sr 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.

About the role

The Senior Medical Project Coordinator manages, coordinates and evaluates 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 the project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel.

Responsibilities

• Work independently to perform 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 summations for safety review meetings.
• Review designated sections of aggregate reports.
• 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 act as the alliance-level lead on larger alliance/multi-protocol studies.
• Create and maintain medical management plan(s) on studies (as applicable) and ensure that the processes included in the plan document are reflective of the contract and services requested for studies that have department involvement and those that are standalone studies (e.g., MM and/or MPC).
• 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 attend risk management meetings to discuss.
• Determine hours required for out-of-scope work for the team and provide this to the finance/study team for contract modifications. Attend meetings to discuss/justify the modification requirements.
• Resolve complex problems through in-depth evaluation of various factors and offer solutions.
• Assist management in training and mentoring.
• Present at business development, client, and investigator meetings and participate in strategy/business development calls. Represent studies at risk management meetings.

Requirements

• Bachelor’s degree in Nursing or related Health Sciences (Physician’s Assistant) or licensed RN.
• 5+ years of clinical safety experience (clinical research monitoring, or pharmacovigilance, or a 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.

Skills

• 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.

Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Benefits

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. 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.