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Lead Clinical Trial Operations Manager
2 months ago
About C4 Therapeutics:
C4 Therapeutics (C4T) is a pioneering biopharmaceutical organization committed to advancing targeted protein degradation science to develop transformative therapies for patients. The company is actively progressing oncology initiatives and leveraging the TORPEDO platform to engineer small-molecule treatments for complex diseases. C4T's degrader therapies are designed to eliminate disease-promoting proteins, ultimately enhancing patient outcomes.
Position OverviewC4 Therapeutics is seeking a seasoned Clinical Operations expert to manage the execution of clinical trials within the oncology domain. The Clinical Trial Manager will formulate operational strategies, lead study execution, oversee third-party partnerships, and ensure compliance with timelines and regulatory requirements.
Key Responsibilities:
- Direct the operational components of clinical studies from inception to final report
- Oversee trial budgets, timelines, and resource distribution
- Collaborate with multidisciplinary teams on trial strategies and implementation
- Supervise study management teams and external partners
- Identify and manage issues and risks, escalating as needed
- Prepare for various meetings and deliver presentations as required
- Monitor study metrics and manage relevant study tools
- Develop vendor management strategies and supervise vendor activities
- Contribute to the creation of study documentation
- Assist in data integrity and protocol deviation documentation
- Guide junior personnel and foster relationships with stakeholders
- Ensure adherence to regulations and internal protocols
Qualifications:
- Bachelor's degree in health/life sciences or a related discipline
- 4-10 years of experience in drug development
- Significant experience in oncology
- Demonstrated leadership, problem-solving, and communication abilities
- Familiarity with FDA Regulations and GCP standards
- Proficient in Microsoft Office Suite
- Ability to work collaboratively and prioritize effectively
- Willingness to travel as necessary
C4 Therapeutics is an Equal Opportunity Employer.