Associate Director (Trial Master File)

DIRECT CLIENT NEED – Immediate interview!!! 

Position: Associate Director (Trial Master File Operations and Systems Management)

Location: Cambridge MA

Duration: 6+ Months

Responsibilities:

• Manage overall TMF operations and third party vendors, and act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities. Lead resolution of issues and remediation activities with the vendor. 

• Manage and provide direction to external TMF Document Specialists and ensure that all documentation activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements and meet appropriate quality standards. 

• Manage and provided direction for internal and external systems used for TMF records. Work with stakeholders to identify issues and remediation activities with vendors. 

• Review document quality audit outputs to identify trends across the portfolio to ensure quality documentation. 

• Identify root cause of performance issues, determine the appropriate remediation, and escalate issues with performance when required. 

• Prepare and deliver effective presentations for external and internal audiences. 

• Represent company to external vendors

Additional Functions:

• Contribute to organizational effectiveness. 

• Effectively serve as a role model within regulatory and cross-functionally. 

• Positively impact industry and agency organizations.

Experience Required:

• 9 years pharmaceutical/biotechnology industry experience. Relevant clinical, regulatory and TMF systems experience preferred. 

• Solid knowledge of applicable regulations. 

• Experience in interpretation of regulations, guidelines, policy statements, etc. 

• Foster effective, positive interactions with other functions, vendors, and partners.

• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. 

• Ability to represent the department in project teams, committees and external meetings. 

• Demonstrate strong organizational and project management skills, including the ability to prioritize personal workload. 

• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical and scientific staff. 

Education: 

• Bachelor’s degree required, Masters or PhD in Biology / Chemistry, Life Sciences, or Drug Development preferred.