Clinical Trial Project Manager

Job description

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives. **Role Objectives:** The **Clinical Project Manager** at WEP Clinical is responsible for the setup, implementation, and management of clinical trials, ensuring patient safety, data integrity, and high-quality delivery in compliance with applicable regulations. This role provides leadership across cross-functional teams, manages client relationships, and is accountable for delivering clinical trials on time, within scope, and within budget. ### The Ideal Candidate: - Adaptable - Detail-oriented - Collaborative - Solutions-focused ### What You'll Do: **The level of appointment (e.g., Project Manager II or Senior Project Manager) will be determined based on the candidate’s experience, skills, and demonstrated capabilities during the interview process.** **Principal Duties and Responsibilities** - Lead the setup, execution, and close-out of clinical trials in compliance with WEP Clinical SOPs, GCP/ICH guidelines, and regulatory requirements. - Provide day-to-day accountability for the operational delivery of assigned clinical trials. - Develop and maintain study manuals, operational project plans, timelines, and key performance metrics. - Ensure proper setup, maintenance, and close-out of eTMF and CTMS systems. **Leadership & Cross-Functional Oversight** - Serve as project team lead and primary point of contact for internal and external stakeholders. - Provide oversight and coordination of cross-functional deliverables including monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing. - Ensure internal and external teams are appropriately trained on study protocols and operational requirements. **Client & Stakeholder Management** - Act as the primary client contact for clinical trial operations, deliverables, and issue resolution. - Lead internal and external meetings, ensuring alignment on project status, risks, and timelines. **Risk & Issue Management** - Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle. - Implement mitigation strategies and corrective actions where required. **Regulatory & Compliance** - Oversee submissions to IRB/ECs and review informed consent forms as required. - Ensure compliance with regulatory requirements and internal quality standards. - Collaborate with Quality Assurance to support audits, CAPAs, and investigations as appropriate. **Financial & Vendor Management** - Manage project budgets, scope, and financial performance. - Oversee vendor performance and deliverables, including review and approval of invoices. - Review site payments and ensure alignment with Clinical Trial Agreements. **Documentation & Systems** - Maintain accurate and complete trial documentation within internal systems (e.g., SharePoint). - Ensure all trial records meet quality and compliance standards. ### What You'll Need: - Bachelor’s Degree (health or science field preferred) - Minimum 5 years’ experience in a Project Manager role within clinical trials or clinical research - Demonstrated experience managing clinical trials from initiation through close-out - Strong working knowledge of ICH GCP guidelines and clinical trial processes - Proven ability to lead cross-functional teams and manage multiple priorities - Strong organizational, problem-solving, and decision-making skills - Effective verbal and written communication skills - Proficiency in Microsoft Office tools - Ability and willingness to travel as required for business needs **Additional Notes** - This role may be filled at different levels depending on experience and demonstrated capability. - Responsibilities may expand in scope with increased seniority and complexity of assigned projects.