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:
- 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.
- 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.
- 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.
- Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle.
- Implement mitigation strategies and corrective actions where required.
- 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.
- 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.
- 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
- 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.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message.
We will never ask for your bank account information at any stage of recruitment.