Senior Clinical Project Manager

Astrix Inc; Boston (MA); Remote; USD 100,000 - 130,000; Full time

Job summary

A leading biotechnology company is looking for a Senior Clinical Project Manager to oversee clinical trial activities. This remote position involves managing study budgets, ensuring regulatory compliance, and leading cross-functional teams. Ideal candidates will have extensive experience in project management within clinical trials, along with proficiency in ICH GCP guidelines and clinical operations.

Qualifications

• Minimum 10-12 years of professional experience, including at least 3 years as a CTM or Clinical Trial Project Manager.
• Solid understanding of project management and regulatory guidelines.
• Experience in developing and managing study-related documents.

Responsibilities

• Oversee study activities, including monitoring reports and TMF checks.
• Track data cleaning metrics and address identified backlogs.
• Ensure the study remains on track with the approved budget and timelines.

Skills

Project management

Clinical operations

Budget management

Collaboration with CRO

Proficiency in ICH GCP guidelines

Education

Bachelor's degree in life sciences, physical sciences, or nursing

Tools

Medidata RAVE

Clinical trial management systems

Excel

Job description

Seeking a Senior Clinical Project Manager for our client - a clinical stage biotechnology company focusing on a potent and unique therapy to treat cancer.

Type: Direct Hire

Location: Remote

Responsibilities:

• Oversee study activities, including reviewing monitoring reports and conducting TMF (Trial Master File) checks.
• Attend status meetings, taking and reviewing meeting minutes as needed.
• Validate service completion through detailed invoice reviews.
• Assist the CRO in resolving site-level issues, including instances of non-compliance.
• Track data cleaning metrics and address any identified backlogs.
• Develop, review, or update essential study documents, such as ICFs, protocols, study plans, and training materials.
• Deliver regular updates on progress and milestones.
• Ensure the study remains on track with the approved budget and timelines.

Qualifications:

• Bachelor's degree in life sciences, physical sciences, or nursing.
• 10-12 years of professional experience, including at least 3 years as a Clinical Trial Manager (CTM) or Clinical Trial Project Manager.
• Previous experience collaborating with a Contract Research Organization (CRO).
• Proficiency in ICH GCP guidelines, U.S. regulations, project management, clinical operations, study budgets, and timeline management.
• Familiarity with Medidata RAVE, clinical trial management systems, and Excel.