eTMF Specialist

The eTMF Specialist facilitates the collection, review, maintenance, and archival of essential regulatory documents for the electronic Trial Master File (eTMF) in accordance with Good Clinical Practice (GCP), ICH E6 Guidelines, other regulatory guidance documents, and Xeris Standard Operating Procedures (SOPs) as appropriate. This position will work closely with the cross functional study team to ensure that the eTMF is inspection ready.

• Collects, organizes, and tracks all essential documents related to a clinical trial, including those generated by the sponsor, investigator, vendors and other relevant parties. 
• Supports the preparation and management of the trial-specific TMF Plan, Index, Study Milestone Design, and Expected Document List ensuring study team and vendor compliance.
• Performs TMF quality reviews, identifies document deficiencies and tracks them to resolution or rejection in coordination with the responsible functional areas.
• Assists with eTMF user access management and eTMF system training from study start up to study archival.
• Assists in the creation, maintenance, close out, transfer and archival of eTMF.
• Participates in audits, inspection readiness preparation and inspection activities as needed.

• Three (3) to five (5) years of experience working in an FDA-regulated environment supporting essential regulatory document collection including collection of documents at study start-up, during study conduct and close-out
• Proficiency with document management systems including uploading, reviewing, quality checks (QC), and approval of essential TMF documents. Experience with Veeva Vault eTMF is preferred
• Working knowledge of FDA and ICH GCP regulations, guidelines, and standards governing regulated clinical research, essential documentation, and good documentation practices
• Working knowledge of the TMF reference model
• Ability to prioritize tasks and deliver assignments with high quality in a timely manner
• Competencies:  Teamwork & Collaboration, Attention to Detail, Self-Starter, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications

• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion.

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As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

The anticipated base salary range for this position is $60,000 to $95,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process

NOTE:  This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.