Clinical Project Manager

*****MUST HAVE RWE EXPERINCE AND CRO MANAGEMENT EXPERIENCE> US ONLY*****

****PLEASE, NO 3RD PARTIES****

Employment Type: 12-Month Contract

Location: United States – East Coast / Eastern Time Zone Preferred

Start Date: ASAP

Industry: Pharmaceutical / Biotechnology

Position Overview

We are partnering with a global biopharmaceutical organization seeking an experienced Senior Clinical Project Manager (CPM) for an immediate 12-month contract opportunity.

This position will focus on the operational oversight and execution of global Real-World Evidence (RWE) and Phase IV/post-marketing clinical studies, with a significant emphasis on CRO oversight and external vendor management.

The ideal candidate will have a strong background managing global clinical research programs, demonstrated success overseeing outsourced clinical operations, and direct experience supporting RWE and Phase IV studies.

Candidates located on the East Coast or able to work Eastern Time Zone business hours are strongly preferred.

Key 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.

Required Qualifications

• 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 or multinational 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.

Preferred Qualifications

• 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.

Contract Details

• Duration: 12 months
• Anticipated Start: ASAP
• Location Preference: East Coast / Eastern Time Zone
• Interview Process: Candidate screening and interviews are being coordinated immediately.