Trial Master File (TMF) Specialist Consultant

General Scope and Summary

SAGE Therapeutics is searching for a Trial Master File (TMF) Specialist Consultant to drive our TMF Health and Inspection Readiness initiatives at the program and/or study level. This Consultant role will require the candidate to be savvy collaborating with cross-functional teams that include Sage, CRO, and eTMF vendor teams.

Roles and Responsibilities

• Work cross-functionally across study teams.

• Liaison between the clinical study teams, CRO staff, and eTMF vendor personnel.

• Project Manage deliverables and reconcile concerns for these teams.

• Monitor Quality Issue (QI) resolution specific to TMF findings.

• Attend and participate in study specific meetings.

• Contribute to TMF Health KPI tracking.

• Perform routine and ad hoc quality and/or completeness checks in the Trial Master File, focusing on identifying trends in completeness, quality, and timeliness.

• Contribute to TMF standardization and risk-based QC efforts.

• Provide input into the development of Clinical Information Systems standards, policies, and procedures.

• Ensure that the use of systems adhere to all established policies, procedures, and standards.

• Work with Clinical Operations study teams to implement and promote best practices, standardizations, utilization, and optimization, keeping in mind TMF Health and Inspection Readiness.

• Provide timely support of TMF-related business processes owned and driven by the Clinical Information Systems Team.

• Actively work to collect feedback to promote end user adoption, acceptance, and an active user community for the TMF.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop trusting relationships, and good conflict management and negotiation skills. 

Basic Qualifications

• 2+ years of experience working in a clinical research (clinical operations) environment.

• Bachelor’s degree required.

Preferred Qualifications

• Advanced degree preferred.

• Veeva Vault Clinical experience preferred.

• Experience working with the TMF Reference Model and understanding of regulatory documents and TMF Content.

• Experience with metrics, reporting, and/or business intelligence tools desired.

• In-depth attention to detail and the ability to work individually, within a multi-disciplinary team and matrix environment, as well as with external partners and vendors.

• Embrace our Core Values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

• Excitement about the vision, mission, and therapeutic focus of Sage.

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law

EEO is the Law - Poster Supplement

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.