Clinical Trial Project Manager

1 week ago

Johannesburg South, South Africa Arborvitae.in Full time

Position Summary: We are seeking a highly motivated and experienced Clinical Trial Project Manager (or Clinical Project Lead) to oversee and coordinate clinical trials across the US and trials across multiple therapeutic areas, including but not limited to Oncology, Medical Devices, and Ophthalmology. This individual will ensure the successful planning, execution, and completion of clinical studies, adhering to timelines, budgets, and regulatory compliance. Key Responsibilities: 1. Project Leadership: - Lead and manage cross-functional project teams for clinical trials across diverse therapeutic areas. - Ensure that study objectives are met within the defined scope, timeline, and budget. 2. Study Design and Planning: - Collaborate with internal stakeholders and sponsors to design study protocols. - Develop comprehensive project plans, timelines, and budgets for clinical trials. 3. Site Management: - Oversee clinical trial activities at sites across the US and EU, ensuring compliance with protocols, GCP, and regulatory guidelines. - Coordinate site selection, initiation, monitoring, and close-out activities. 4. Vendor Management: - Manage relationships with CROs, central labs, and other third-party vendors to ensure quality deliverables. - Monitor vendor performance and adherence to contractual obligations. 5. Regulatory and Compliance: - Ensure all trial activities comply with local and international regulatory requirements. - Collaborate with QA teams to address audit findings and implement corrective actions. 6. Data Management: - Partner with data management teams to ensure accurate and timely data collection and analysis. - Provide regular study status updates to stakeholders. 7. Risk Management: - Identify potential risks to project timelines or quality and implement mitigation strategies. - Escalate critical issues to senior management as needed. Qualifications: - Education: - Bachelor's degree in life sciences, health sciences, or a related field (Master’s preferred). - Experience: - 3-5 years of experience in clinical trial management across various therapeutic areas, including Oncology, Medical Devices, and Ophthalmology. - Proven experience managing multi-regional clinical trials in the US, EU & Africa. - Technical Skills: - Strong understanding of clinical trial design, ICH-GCP guidelines, and regulatory requirements (FDA, EMA). - Proficiency in project management tools (e.g., MS Project) and clinical trial management systems (CTMS). - Soft Skills: - Excellent organizational, communication, and leadership skills. - Ability to manage multiple priorities and work effectively in a fast-paced environment. Preferred Qualifications: - Experience with early-phase (Phase I/II) or investigator-initiated studies. - PMP certification or equivalent project management training. - Familiarity with electronic Trial Master File (eTMF) systems. **Job Types**: Full-time, Permanent

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