Senior Manager, Trial Master File Management at Larimar Therapeutics

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Jul, 26

Salary

0.0

Posted On

10 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Trial Master File Management, eTMF, Veeva Vault, Clinical trial lifecycle, CDISC TMF Reference Model, ICH-GCP, Regulatory compliance, Document management, Vendor oversight, Data integrity, ALCOA++, Project management, Critical thinking, Training, Inspection readiness

Industry

Biotechnology

Description

Description The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Job Responsibilities: Position Overview: The Senior Manager of Trial Master File Management will support the cross-functional study team and the Larimar Trial Master File Management team with the day-to-day management of study-specific TMFs and the oversight of the eTMF and TMF and eTMF vendors. Key Responsibilities: Support the cross-functional Larimar internal and vendor external study team by providing ongoing support and management of study-specific TMFs to ensure compliance with ICH-GCP, all applicable local regulatory requirements, and Larimar’s cross-functional business processes Participates in departmental process improvement including the review of TMF and eTMF procedures and tools and identify gaps and trends for improvement Provides regular updates to all internal and external study team meetings Provides metrics and KPIs/KQIs to different stakeholders including the study team, department, and/or management team, as required Oversees compliance with TMF procedures and plans Works cross-functionally with internal and external study team members to ensure that TMF documents are submitted on an ongoing basis as required by TMF SOPs and Plans. Supporting the management of Veeva and functional system releases, as needed Support with the oversight and management of vendors with document filing and document-level QC Support with the review or eTMF and TMF system guides, tools, reference materials. Serve as the TMF subject matter expert (SME) for study team members for questions related to document management/TMF and the eTMF system Lead TMF and eTMF training for internal and external study team members and support with the development and review of TMF and eTMF-related training materials and resources Setup and management of study data in the eTMF such as metadata for studies, countries, sites, personnel and organizations, and milestones Serve as the archivist for the eTMF Support with the management of the TMF mailbox Participates in departmental team meetings Other/ad hoc activities to support Trial Master File Management and Inspection Readiness related deliverables as needed Requirements Required Qualifications: BA/BS degree with 5+ years of relevant experience in the pharmaceutical industry working at a clinical research organization and/or vendor, or pharmaceutical/biotechnology company Experience with eTMF systems including for example, Veeva Vault, Wingspan, Trial Interactive, etc. Strong written and verbal communication skills Ability to develop strong working relationships with internal and external TMF stakeholders Thorough understanding of the clinical trial lifecycle and clinical development processes Strong knowledge of the CDISC TMF Reference Model Strong knowledge of regulatory requirements related to document management including for example ICH-GCP, FDA, EMA, MHRA, etc. Experienced with Good Documentation/Data Integrity Practices including ALCOA++ Ability to multitask, work well under pressure, and manage several projects with competing priorities Proven ability to problem-solve, make decisions, and apply critical thinking skills Experience in overseeing vendors and/or in managing people Preferred Qualifications: Experience with Veeva’s Vault platform and/or the Veeva Vault eTMF Experience managing filing support through a FSP vendor Strong understanding of Sponsor oversight obligations Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.

Responsibilities

The Senior Manager will oversee study-specific Trial Master Files (TMF) and manage eTMF vendors to ensure regulatory compliance and inspection readiness. They will also serve as a subject matter expert, providing training and metrics to cross-functional study teams.