Position Summary:
We are seeking an experienced and highly organized Clinical Trial Manager (CTM) to join our team and oversee the successful planning, execution, and delivery of clinical trials. The CPM will play a crucial role in the management of clinical development programs, ensuring that trials are conducted efficiently, on time, and in compliance with regulatory requirements. The ideal candidate will possess strong leadership, communication, and problem-solving skills, as well as a deep understanding of clinical trial management within a small biotech environment.
Key Responsibilities:
- Project Leadership: Lead and manage the planning, execution, and close-out of clinical trials, ensuring timelines, budgets, and quality standards are met.
- Study Design & Strategy: Collaborate with internal stakeholders, including clinical operations, regulatory affairs, and medical affairs, to develop study protocols, budgets, and timelines.
- Vendor Management: Oversee relationships with external vendors (CROs, labs, etc.) and ensure timely and accurate execution of study activities.
- Risk Management: Proactively identify potential risks or challenges and work with the team to mitigate them, ensuring minimal impact on study timelines and objectives.
- Team Coordination: Coordinate with cross-functional teams, including clinical research associates (CRAs), data management, regulatory, and medical teams, to ensure alignment and execution of trial objectives.
- Regulatory Compliance: Ensure that all clinical trials are conducted in compliance with Good Clinical Practice (GCP), local regulations, and company SOPs.
- Budget & Resource Management: Monitor trial budgets, track spending, and optimize resource allocation to ensure cost-effective execution of clinical studies.
- Clinical Trial Monitoring: Oversee the monitoring of clinical trial progress, ensuring sites are recruited and managed appropriately and that data is collected and reported accurately.
- Documentation & Reporting: Review and approve study-related documentation, including clinical trial agreements, informed consent forms, and clinical study reports. Ensure timely and accurate reporting to stakeholders and regulatory agencies.
- Training & Development: Provide training to internal team members on clinical trial processes and best practices.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's or higher preferred).
- 3-5 years of experience in clinical project management, preferably within a biotech or pharmaceutical setting.
- Strong knowledge of clinical trial design, regulatory requirements (FDA, EMA), and ICH-GCP guidelines.
- Experience working with CROs and external vendors.
- Demonstrated ability to manage multiple projects and priorities in a fast-paced environment.
- Excellent communication, leadership, and interpersonal skills.
- Strong problem-solving skills and ability to work under pressure.
- Proficiency in clinical trial management software and Microsoft Office Suite.
- Ability to travel as needed for site visits and meetings.
Preferred Qualifications:
- Experience in early-phase clinical trials (Phase 1/2).
- Familiarity with electronic data capture (EDC) systems and other clinical trial management tools.
- Certification in clinical research (eg, PMP, CCRA, etc.) is a plus.