Lead Medical Project Coordinator

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Work independently to perform and/or lead 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 comprehensive summations for safety review meetings. • Initiate and lead initiatives to improve current processes and develops new processes regarding medical monitoring and department services. • 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 safety and medical management plan(s) on studies (as applicable) and ensure that the processes included in the plan document are reflective of the contract and service requested for studies that have department involvement as well as 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. • Present at business development, client, and investigator meetings and participate in strategy/business development calls. • Represent studies at risk management meetings. • Independently determine hours required for out of scope work for both the MM and MPC and provides this to the finance/study team for contract modifications. • Attend meetings to discuss/justify the modification requirements. • Train and develop new team members. • Serve as main point of contact for team member questions with escalation to management as appropriate. • May provide input on individual performance to direct line manager. • Organize and lead meetings with team members to discuss potential process issues, answer questions, and brainstorm ideas and solutions. • Resolve complex problems through in-depth evaluation of various factors and offers solutions.

🎯 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 8+ years), to include 8+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)

🏖️ Benefits

• Health and wellbeing support • Professional development opportunities