Senior Manager, eTMF Management

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts

Summary

Tango has an exciting new opportunity to join the team as our first Trial Master File Manager to support strategy, governance, training, and maintain documentation related to TMF activities across the portfolio. You will report to the Director of Clinical Compliance.  You will manage filing and maintenance activities for clinical trials during the study start-up, maintenance, and close-out periods. You will be detail oriented with a flexible and solution-oriented outlook, and the ability to support clinical team members within Tango and across our CRO partners.

Your role:

• You will maintain effective communication with project teams, CRO staff, and vendors throughout study start-up, maintenance, and close-out.
• Support study document filing into the trial TMF
• Review and ensure compliance and oversight of TMF plans
• Perform routine quality checks of documents uploaded into the TMF across trials, and ensure findings are documented and resolved in a timely manner
• Respond to inquiries regarding TMF management and contents
• Attend departmental and study-specific meetings and discussions, as required
• Run routine TMF reports and monitor for completeness and trends
• May provide TMF training to new team members
• Perform general administrative tasks
• Complete other study document-related tasks as required by the study teams
• Additional duties and responsibilities as required

What you bring:

• Life sciences degree or certification in a related allied health field
• 3-5 years’ experience with clinical trials (e.g., study coordinator, regulatory operations) and electronic TMF document management experience
• Clear and timely communication skills
• Understanding of GCP and regulatory requirements as well as a working knowledge of clinical research documents, their contents and purpose
• Demonstrated proficiency with MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.