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Aerotek TMF Lead (100% Remote) in Boston, Massachusetts

Company: TOP Pharma company that currently has 9 FDA approved medicines and a robust pipeline of trials from phases I-IV. 100% of drug candidates are invented and developed in house and they have been on Forbes 100 Best Companies to Work For list for the past 5 years straight! They have a great culture and are rapidly growing. Amazing opportunity to join a leading pharmaceutical company and grow from within!

Role: TMF Lead

Summary: The TMF Lead is responsible for leading 8-12 studies from a TMF standpoint (setting up, overseeing and managing the Veeva TMF). Creates and maintains the TMF plan and the study specific inventory list. Advise the study team about the status of the TMF (completeness, quality and timeliness) and ensures the completion and resolution of the periodic quality reviews. Responsible for locking the TMF at the end of the study following approval by all functional areas. Responsible for ensuring the TMF is inspection ready at ALL times.

Qualifications:

  • DIA TMF Reference Model Subject Matter Expert (SME)

  • 3+ years of TMF Experience (Pharma/CRO/Biotech/Vendor)

  • Experience ensuring that the TMF is inspection/audit ready at all times

  • Experience educating Study Teams on the eTMF and presenting at study team meetings

  • Ability to create a TMF plan and ensure compliance by the study team

  • Associates Degree minimum; Bachelors Degree preferred

Benefits: PTO/Holiday; 401K; Medical, Dental Vision, etc.

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About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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