Senior Medical Project Coordinator

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee, coordinate, and assess medical projects for one or more programs throughout their entire lifecycle.

• Collaborate effectively with management, stakeholders, client personnel, and clinical project teams.

• Conduct initial reviews of safety data utilizing line listings, dashboards, and visualization tools.

• Analyze safety data for trends, consistency in coding, and potential follow-ups with investigator sites.

• Identify, address, or escalate potential issues as necessary.

• Prepare summaries of safety data for safety review meetings.

• Review specified sections of aggregate reports.

• Serve as Project Lead for medical monitoring services when SAE case processing is not contracted.

• Oversee study implementation, coordination, maintenance, and closure.

• Act as the main point of contact for clinical project teams and the alliance-level lead on larger studies.

• Develop and maintain medical management plans, ensuring alignment with contracts and requested services.

• Track project financial status, including forecasting, realization, and team allocations.

• Coordinate staff projections based on contract values and actual hours worked.

• Escalate financial and operational risks and engage in risk management meetings.

• Determine hours required for out-of-scope work and assist with contract modifications.

• Address complex challenges and propose effective solutions.

• Support management in training and mentoring initiatives.

• Deliver presentations at business development, client, and investigator meetings.

• Participate in strategy and business development discussions.

• Represent studies during risk management meetings.

⛳️ Requirements

• Bachelor's degree in Nursing or a related Health Sciences field, such as a Physician's Assistant, or a licensed RN.

• At least 5 years of experience demonstrating relevant knowledge, skills, and abilities.

• A minimum of 5 years of clinical safety experience in clinical research monitoring, pharmacovigilance, or a combination of both.

• Equivalent education, training, and/or directly related experience may be taken into account.

• Extensive knowledge of GCPs for medical oversight of clinical trials.

• Understanding of drug development and safety reporting processes.

• Advanced expertise in safety data trending, including coding practices.

• Familiarity with biostatistics, data management, and clinical procedures.

• Exceptional problem-solving and critical-thinking abilities.

• Strong project management and budgeting skills.

• Effective mentoring skills, with the capability to train and lead others.

• Excellent oral and written communication skills.

• Keen attention to detail.

• Ability to work collaboratively within a team.

• Capacity to maintain a positive and professional demeanor in challenging situations.

🏝️ Benefits

• Support for a healthy and balanced work environment.

• Reasonable accommodations available for individuals with disabilities.

• Opportunities for career development and collaboration.