Position Overview:
We are seeking a dedicated and detail-oriented Clinical Trial Manager (CTM) to oversee the planning, execution, and management of clinical trials. The ideal candidate will have a strong background in clinical operations and a passion for advancing clinical research within a small biotech environment.
Key Responsibilities:
- Study Planning and Execution:
- Lead the design and implementation of clinical trial protocols, including site selection, patient recruitment strategies, and timeline development.
- Project Management:
- Manage all aspects of clinical trial operations, ensuring adherence to timelines, budgets, and regulatory requirements.
- Team Leadership:
- Collaborate with cross-functional teams including clinical research associates, data managers, and regulatory affairs to ensure successful trial execution.
- Site Management:
- Establish and maintain strong relationships with clinical trial sites. Provide ongoing support and oversight to ensure compliance with protocol and regulatory standards.
- Data Integrity and Compliance:
- Monitor trial progress, ensuring accurate data collection, timely reporting, and adherence to Good Clinical Practice (GCP) guidelines.
- Risk Management:
- Identify potential study risks and develop mitigation strategies to ensure successful trial outcomes.
- Communication:
- Prepare and present updates to stakeholders, including internal teams and external partners. Facilitate regular meetings to discuss study progress and address challenges.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, or related field (advanced degree preferred).
- 5+ years of experience in clinical trial management within a biotech or pharmaceutical environment.
- Strong understanding of clinical trial regulations and guidelines (FDA, ICH, GCP).
- Proven ability to manage multiple projects simultaneously and work independently.
- Excellent organizational, communication, and interpersonal skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.