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.

• Work collaboratively with management and stakeholders to ensure consistency in processes, alignment, compliance, performance, and issue resolution throughout the project lifecycle.

• Act as the company representative within the medical research community while fostering collaborative relationships with client personnel.

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

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

• Identify, address, or escalate issues as necessary.

• Review safety data and compile summaries for safety review meetings.

• Examine designated sections of aggregate reports.

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

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

• Act as the primary contact for clinical project teams and serve as the alliance-level lead on larger alliance or multi-protocol studies.

• Develop and maintain medical management plans ensuring processes align with contracts and requested services.

• Monitor the financial status of projects, including unit forecasting, realization, and team allocations.

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

• Escalate financial and operational risks and take part in risk management discussions.

• Assess hours needed for out-of-scope work and assist with contract modifications.

• Participate in meetings to discuss and justify modification requirements.

• Resolve complex issues through thorough evaluation and propose effective solutions.

• Support management in training and mentoring initiatives.

• Present at business development, client, and investigator meetings while participating in strategy and business development calls.

⛳️ Requirements

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

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

• Equivalency may be considered through a combination of relevant education, training, and directly related experience.

• Advanced understanding of GCPs for the medical oversight of clinical trials.

• Familiarity with drug development processes and safety reporting.

• In-depth knowledge of safety data trending, including coding practices.

• Working knowledge of biostatistics, data management, and clinical procedures.

• Exceptional problem-solving and critical thinking abilities.

• Strong project management and budgeting skills.

• Effective mentoring capabilities with the ability to train and lead others.

• Excellent oral and written communication skills.

• Meticulous attention to detail.

• Ability to collaborate effectively within a team environment.

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

🏝️ Benefits

• Healthy and balanced work environment.

• Opportunities for collaboration and professional development.

• Resources and support for career development.