Note: The job is a remote job and is open to candidates in USA. Connect Life Sciences is recruiting for an unnamed global biopharmaceutical organization seeking a Senior Clinical Project Manager on a 12-month contract. The role oversees global Real-World Evidence and Phase IV/post-marketing studies, with a focus on outsourced clinical operations, CRO oversight, and vendor management.
Responsibilities
- Oversee the planning, execution, and delivery of global RWE and Phase IV/post-marketing clinical studies
- Provide hands-on oversight of external CRO partners, ensuring accountability for study timelines, deliverables, budgets, and quality expectations
- Serve as a key point of contact for CROs and external vendors, facilitating regular project meetings, performance reviews, and issue resolution
- Develop and maintain project plans, study timelines, risk assessments, and operational tracking tools
- Monitor CRO performance, identify potential challenges, and implement proactive risk mitigation strategies
- Collaborate with cross-functional stakeholders, including Clinical Operations, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Data Management, and Biostatistics
- Support the operational execution of observational studies, patient registries, and other post-marketing research initiatives, as applicable
- Ensure compliance with applicable global regulations, internal SOPs, and relevant clinical research quality standards
- Provide regular project updates and communicate study progress, risks, and milestones to internal leadership
- Drive operational excellence and ensure successful delivery of outsourced clinical research activities
Skills
- Bachelor's degree in Life Sciences, Healthcare, or a related discipline
- Extensive experience in clinical project management within the pharmaceutical, biotechnology, or CRO industry
- Strong, hands-on CRO oversight experience, including managing outsourced clinical study activities, vendor performance, and deliverables
- Direct experience with Real-World Evidence (RWE) and/or Phase IV/post-marketing clinical studies
- Experience managing global clinical research programs
- Demonstrated ability to manage complex study timelines, budgets, and cross-functional deliverables
- Strong understanding of clinical research regulations, global study operations, and applicable quality requirements
- Excellent communication, organizational, problem-solving, and stakeholder management skills
- Ability to work independently and effectively oversee external partners
- Located on the East Coast or available to work Eastern Time Zone business hours
- Previous experience within a global pharmaceutical or biotechnology organization
- Experience with observational research, patient registries, post-authorization safety studies, or other RWE programs
- Experience managing multiple CROs and external vendors across international regions
- Strong knowledge of vendor governance, risk management, and outsourced clinical research models
Company Overview