Planet Pharma · 7 hours ago
Clinical Trial Specialist
United States
Contract
Remote
Senior Level
$50/hr - $55/hrPlanet Pharma is advancing externally sponsored research initiatives, and they are seeking a Senior Manager to lead the operational execution of Investigator Initiated Studies and Research Collaborations. This role involves managing relationships with investigators and overseeing the full lifecycle of research projects to ensure high-quality execution.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Katarina Cruz
Responsibilities
Serve as the primary point of contact for IIS and RC activities across regions
Manage communications and relationships with investigators, academic partners, and internal stakeholders
Oversee the full lifecycle of externally sponsored research, including concept intake, review, budget approval, contracting, study execution, and close-out
Coordinate Medical Affairs Review Board (MARB) meetings, including agenda development, document preparation, and minutes management
Track IIS/RC metrics and provide regular updates to Medical Affairs leadership
Ensure inspection readiness through complete, accurate, and readily retrievable documentation
Partner with GPSRM and QA to support audits and inspections
Provide oversight and collaborate with IIS portal vendor on issues and updates
Accountable for ensuring drug shipment activities comply with local/regional requirements and quality standards
Management of IIS and RC budgets, including annual budget planning
Proactively identify operational challenges and propose practical solutions
Contribute to initiatives aimed at improving investigator experience and internal efficiencies
Uphold and model clients in every aspect of work
Qualification
Required
BA/BS in Life Sciences or related field is required
Proven experience in the pharmaceutical/biotech industry, prior experience in Clinical Operations and/or Medical Affairs supporting GCP/GPP studies
Strong working knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Excellent verbal and written communication skills
Strong relationship-building and stakeholder management capabilities
Highly organized, detail-oriented, and able to work independently
Solution-oriented mindset with strong problem-solving skills
Committed to high quality, integrity and alignment with Core Values
Preferred
Advanced degree or certification preferred
Experience managing externally sponsored research (IIS/RC) strongly preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
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