Invenia Group has partnered with a dynamic and innovative biotechnology company dedicated to advancing healthcare through cutting-edge research and the development of novel therapies. They are seeking a talented and motivated Senior Clinical Trial Manager to join the team and play a vital role in advancing their mission in oncology and CAR-T.
This role is remote and can be based anywhere in the US.
Job Description
- As a Clinical Trial Manager, you will lead and drive Phase I, II and III clinical trials globally.
- You will work alongside a highly skilled and passionate team of professionals in a collaborative and dynamic environment.
Key Responsibilities
- Plan, design, and execute clinical trials in compliance with regulatory guidelines and company standards.
- Oversee and manage all aspects of clinical trial operations.
- Collaborate with cross-functional teams, including medical affairs, regulatory affairs, and data management, to ensure the successful execution of clinical trials.
- Develop and manage clinical trial budgets, timelines, and resources effectively.
- Ensure the quality and integrity of clinical trial data by maintaining adherence to GCP (Good Clinical Practice) standards.
- Manage and communicate with external vendors, CRO, and investigative sites.
- Lead the preparation and submission of regulatory documents and applications.
Qualifications
- Bachelors or advanced degree in life sciences or a related field.
- Previous Biotech experience is mandatory.
- At least five years of experience in biotech or pharmaceutical industry clinical trial management.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Proven experience in protocol development, site selection, and clinical trial initiation.
- Excellent project management skills and the ability to manage multiple tasks simultaneously.
- Strong communication and leadership skills with the ability to work collaboratively in a team environment.
- Detail-oriented with a commitment to data integrity and quality.
What’s on offer?
- A competitive compensation including 12% bonus + shares.
For more information, please apply.