Sr Medical Project Coordinator

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

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 project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel. 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 can 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 (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. Independently 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 offers solutions. May assist management in training and mentoring. Present at business development, client, and investigator meetings and participates in strategy/business development calls. Represent studies at risk management meetings.

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), to include 5+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance) In some cases an equivalency,