ACCELERON PHARMA INC Manager, Trial Master File (TMF) Salary in the United States

What’s in it for you?

We are seeking an experienced and talented individual who thrives in a dynamic, collaborative, fast-paced, and team-centric environment. As a Manager of our Trial Master File (TMF) team, you will oversee and manage all aspects of eTMF activities for assigned global clinical trials. You will collaborate with cross-functional team members, contract research organizations and partnering vendors to ensure continuous process improvements and inspection readiness in TMF.

What will you be doing?

• Management and oversight of TMF study initiation activities (e.g., TMF set-up and metrics monitoring through-out study life, TMF timelines, project presentations, kick-off meeting TMF trainings, quality management, migrations, and archive)
• Work proactively and prospectively with Clinical Trial Managers, TMF contributors, and TMF document owners at Trial, Country, and Site levels to ensure inspection readiness
• Manage special projects with ability to solve TMF challenges
• Author and contribute to the development of SOPs, work instructions, TMF Plans, and other tools to ensure compliance with applicable regulations, policies, and practices

What are we looking for?

• Bachelor’s degree required; Master’s degree preferred
• Minimum 5 years of pharmaceutical industry experience related to clinical trial management
• Strong skill set in e-TMF technology and reporting
• Significant understanding of, and experience with the DIA TMF Reference Model
• Previous experience in managing and archiving clinical trial related documentation
• Possess a high degree of ingenuity and the ability to work and lead cross-functional teams/studies/initiatives
• Extensive understanding of regulatory requirements, guidances, and industry standards that govern TMF
• Excellent organizational skills
• Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, Visio etc.)
• Ability to work full-time, on-site, or remotely during core corporate hours at the Acceleron offices in Cambridge. If full time remote, trips to the office will be required on a regularly scheduled basis or as needed to support on-site audits and/or inspections

How will you grow with us?

As a member of the TMF team, this role provides an exciting opportunity to impact the compliance and success of multiple programs. This role provides a tremendous opportunity to gain experience in TMF in a dynamic, fast-paced, and innovative company. Join our team to achieve shared goals while having Too Much Fun along the way!

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com