What are the responsibilities and job description for the Clinical Trial Operations Manager position at Tempest Therapeutics?
**About the Role:**
We are seeking a highly motivated and experienced clinical trial manager to contribute to the operational execution of global, pivotal clinical trials.
The successful candidate will be a key member of the clinical operations team and will be responsible for overseeing various aspects of the trial from startup through closeout, ensuring adherence to timelines, quality standards, and regulatory requirements.
Responsibilities:
- Contribute to the planning, implementation, and execution of global, pivotal clinical trials.
- Develop and manage study timelines, budget, and resources.
- Oversee the selection, contracting, and management of CROs, vendors, and investigative sites.
- Prepare and/or review/approve study-related documents.
- Ensure compliance with GCP, ICH guidelines, and all applicable regulations.
- Proactively identify and mitigate potential risks to trial execution.
