We are seeking a Senior Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development team, focusing on oncology programs. This role, reporting to the VP of Clinical Operations, involves preparing study materials, tracking enrollment, managing relationships with study sites and vendors (especially CROs), overseeing study activities, and identifying project risks.
Responsibilities:
- Act as the Clinical Operations contact for clinical studies, ensuring compliance with ICH/GCP and regulatory requirements.
- Manage CROs and other vendors from initial contact to final deliverables.
- Lead the trial management team to ensure adherence to regulations and internal SOPs.
- Coordinate CRO activities, including clinical monitoring, data management, and safety oversight.
- Contribute to study documents such as protocols and informed consent forms.
- Develop and maintain study timelines and deliverables in collaboration with stakeholders.
- Identify and mitigate potential study risks proactively.
- Create training materials for study teams, investigational sites, and vendors.
- Attend key site visits and support the management of the Trial Master File (TMF).
Qualifications:
- Bachelor’s degree in a biomedical, life sciences, or related field.
- Minimum of 5 years of trial management experience in pharma, biotech, or CRO, with oncology experience required.
- Strong understanding of global regulatory requirements.
- Excellent organizational, teamwork, and problem-solving skills.
- Critical thinking and strategic insight to drive study outcomes.
- Effective verbal and written communication skills.
- Ability to collaborate and influence in a fast-paced environment.
