Clinical Project Manager

We are a clinical-stage biotechnology company committed to developing innovative treatments for cancer.

As a member of our team, you will have the opportunity to work closely with cross-functional teams to plan, implement, and execute global clinical trials.

About the Role:

This position involves contributing to the operational execution of a global, pivotal clinical trial.

The successful candidate will have a strong understanding of clinical trial methodology, GCP, ICH guidelines, and relevant regulations.

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.

Education and Experience:

• 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.