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Sr. Manager, Trial Master File

Company: Aerotek
Location: Hampton
Posted on: April 10, 2021

Job Description:

Description:The Sr Manager, TMF and GDO Systems will serve as a subject matter expert and primary point of contact for activities associated with ensuring TMFs meet the expectations of Health Authorities/Regulatory Agencies from a compliance and archival perspective.

  • These activities include supporting the Clinical Trial Manager (CTM)/ Clinical Trial Associate (CTA) with creation of TMF Plans, as well as, closure and archival of TMFs and ensuring TMF inspection readiness. In addition, the Sr Manager is responsible for maintaining the GDO File Room and its content to ensure an inspection ready state at all times.
  • This System Management component of this role is responsible for the delivery and operational ownership of clinical systems utilized by the GDO group and serves as the primary point of contact for these systems.
  • Currently, these systems include the electronic Trial Master File (eTMF), SharePoint, and the Clinical Integrated Dashboard, but could include others as the need evolves. The Sr Manager will partner with and lead interactions with managers in relevant functional areas (e.g. Clinical Operations, Information Technology (IT) and Quality Assurance (QA)) and manage vendors who are directly involved in activities related to GDO Clinical Trial related systemsSkills:TMF Reference ModelVeeva Vault 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.

Keywords: Aerotek, Bethlehem , Sr. Manager, Trial Master File, Executive , Hampton, Pennsylvania

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