What are the responsibilities and job description for the Clinical Trial Manager position at Tempest Therapeutics?
**Clinical Trial Manager/Senior Clinical Trial Manager Job Description**
**Job Summary:**
We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM) to contribute to the operational execution of a global, pivotal clinical trial.
**Responsibilities:
- Contribute to the planning, implementation, and execution of a global, pivotal clinical trial.
- Develop and manage study timelines, budget, and resources.
- Oversee the selection, contracting, and management of CROs, vendors, and investigative sites, and ensures that performance expectations are met.
- Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
- Ensure compliance with GCP, ICH guidelines, and all applicable regulations.
- Proactively identify and mitigate potential risks to trial execution.
**Site Management:
- Support site selection, qualification, initiation, and monitoring activities.
- Ensure timely enrollment and data collection at clinical trial sites.
- Address and resolve site-related issues effectively.
**Communication and Collaboration:
- Foster effective communication and collaboration within the study team and with external stakeholders.
- Provide regular updates on trial progress to senior management.
- Lead cross-functional and clinical operations team meetings.
- Contribute to the preparation of study reports, presentations, and publications.
**Vendor Management:
- Oversee the performance of CROs and other vendors involved in the trial.
- Ensure vendor compliance with contractual obligations and quality standards.
**Data Management:
- Collaborate with the data management team to ensure data integrity and timely database lock.
- Review and analyze clinical trial data to identify trends and potential issues.
**Regulatory Compliance:
- Maintain accurate and complete trial documentation.
- Contribute to the preparation of regulatory submissions (e.g., IND, CTA).
- Ensure compliance with all applicable regulations and guidelines.
**Requirements:
- Bachelor's degree in a life sciences discipline; advanced degree (e.g., MS, PhD) preferred.
- Experience: CTM - Minimum of 5-7 years of experience in clinical trial management, with at least 1 year in oncology and 2 years as a study manager. OR Sr. CTM - Minimum of 7-9 years of experience in clinical trial management, with at least 2 years in oncology and 4 years as a study manager.
- Strong understanding of clinical trial methodology, GCP, ICH guidelines, and relevant regulations.
- Experience with all phases of clinical trial execution, from startup to closeout.
- Excellent project management, organizational, and communication skills.
- Must be able to develop and present varied and unique ideas.
- Proven ability to work independently and as part of a team.
- Ability to travel up to 15% of the time.
**About Tempest Therapeutics:**
Tempest Therapeutics is a clinical-stage biotechnology company developing small molecule therapeutics to treat cancer through mechanisms that directly kill tumor cells and activate tumor-specific immunity.
The company's leadership comprises experienced oncology drug discovery and development professionals who share a common goal of advancing novel therapeutics that will bring meaningful benefit to patients.
