Jobs · Research · North Carolina

Senior Medical Project Coordinator

Thermo Fisher Scientific · North Carolina, United States · 1 mo ago
RemoteRemoteResearchFull-time

About the role

Thermo Fisher Scientific is seeking a Senior Medical Project Coordinator to manage, coordinate, and evaluate medical projects across one or more programs. The role supports clinical trials in 100+ countries, collaborating with internal teams and client personnel to ensure consistency, alignment, compliance, and optimal performance throughout the project lifecycle.

Responsibilities

  • 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.
  • Works independently to perform first‑pass review of safety data, utilizing line listings, company dashboards, and other visualization tools.
  • Reviews data for safety trends, coding consistencies, and potential follow‑up with investigator sites.
  • Proactively identifies any 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 as applicable.
  • 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 (as applicable) and ensures that the processes documented reflect the contract and services requested for both department‑involved and standalone studies (e.g., MM and/or MPC).
  • Works independently to monitor project financial status, unit forecasting, actual realization, and team allocations in systems.
  • Coordinates staff projections based on contract values and actual hours used.
  • Escalates any financial and/or operational risks and may attend risk‑management meetings to discuss them.
  • Independently determines hours required for out‑of‑scope work and provides this information to finance/study teams for contract modifications.
  • Attends meetings to discuss and justify modification requirements.
  • Resolves complex problems through in‑depth evaluation of various factors 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.

Education and Experience Requirements

  • Bachelor’s degree in Nursing or related Health Sciences (Physician’s Assistant) or a licensed RN.
  • At least 5 years of clinical safety experience (clinical research monitoring, pharmacovigilance, or a combination of both), comparable to the responsibilities of this role.
  • Equivalency may be considered when a combination of appropriate education, training, and directly related experience meets the requirements.

Knowledge, Skills, and Abilities

  • Advanced knowledge of GCPs for medical oversight of clinical trials.
  • Knowledge of drug development and safety reporting.
  • Advanced knowledge of safety data trending, including coding.
  • Working knowledge of biostatistics, data management, and clinical procedures.
  • Excellent problem‑solving and critical‑thinking skills.
  • Strong project‑management and budget management abilities.
  • Effective mentoring skills with the ability to train and lead others.
  • Strong oral and written communication skills.
  • Strong attention to detail.
  • Ability to work collaboratively in a team environment.
  • Ability to maintain a positive and professional demeanor in challenging circumstances.

Work Schedule

Standard (Mon‑Fri)

Working Environment

Office setting. Thermo Fisher Scientific values the health and wellbeing of its employees and encourages a healthy, balanced environment where individuals can thrive.

Why join us?

Joining Thermo Fisher Scientific means becoming part of a global team that values passion, innovation, and scientific excellence. You’ll work in a collaborative environment where development is part of everyday experience, and your contributions truly make a difference in delivering tomorrow’s breakthroughs.

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