Clinical Operations Trial Master File Manager

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 (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.

We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, manufacturing and CMC.

Our company’s strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team’s know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Job Responsibilities:

The Clinical Operations Trial Master File Lead is a vital member of the Clinical Operations Team within the Clinical Operations organization. This role will oversee the management of the Clinical Operations owned and contracted Trial Master File (TMF) documentation across multiple studies. This role involves experience in document management processes, ensuring compliance with regulatory requirements, and providing guidance to the Clinical Operations team and clinical vendors. The Clinical Operations TMF Lead will also play a key role in inspection readiness, process improvements, and training initiatives. This person will also work cross-functionally with Quality, Regulatory Affairs, and Clinical Document Management to ensure accuracy, completeness, and timeliness for filing of the clinical documents in the TMF. The Clinical Operations Trial Master File Lead will also oversee clinical operations managed vendors as appropriate.

• Strategically manage the document lifecycle in Veeva Vault eTMF, including the collection and/or creation, review, and approval of documents while ensuring alignment with study timelines, internal SOPs and regulatory requirements.
• Working with the Clinical Operations team and any Clinical Operations managed vendors to ensure that the TMF Index accurately reflects all TMF documents to be collected and filed in the TMF throughout the study
• Lead milestone-driven Clinical Operations TMF quality reviews, ensuring that documents are complete, high-quality, filed per TMF Index and that all Clinical Operations owned and/or outsourced documentation (i.e., documentation required to be collected/generated by a Clinical Operations managed vendor) has been filed in the relevant sections of the TMF..
• Serve as the TMF Champion for the Larimar Clinical Operations team providing support to the Clinical Operations team as necessary.
• Lead efforts to identify, communicate, and resolve document issues,, discrepancies, gaps, and trends across Clinical Operations documentation. Work closely with vendors, Clinical Operations, and Clinical Document Management and Quality departments to implement corrective actions (as applicable).
• Oversee Clinical Operations vendors to ensure that they are complying with TMF procedures, including timely filing of TMF documents and resolution of any TMF queries.
• Support the Clinical Operations study team with filing documents in the TMF as they are collected and/or generated
• Maintain study specific document trackers (e.g., study team rosters, study document tracker, etc.), ensuring that information within the trackers are kept up to date as the study progresses.
• Responsible for oversight and management of Clinical Operations vendors to ensure compliance with Larimar TMF procedures.
• Ensure inspection readiness of Clinical Operations TMF documents and support audits and regulatory inspections as necessary.
• Lead and manage the relationship with clinical TMF-related vendors, ensuring appropriate contract scope, budgets, vendor performance and issue resolution.
• Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document Lists (EDL) (including managing data for requiredness values and number of expected documents), ensuring alignment with Study Specific TMF Plan and the TMF index.
• Generate, and communicate performance metrics and KPIs to study teams, functional leadership, and management, identifying issues, trends, and opportunities for improvement.

Requirements:

Experience & Knowledge

• Understanding of ICH-GCP and regulatory requirements as they apply to the Trial Master File, specifically for Clinical Operations.
• Experience in document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum, etc.)
  Contributes to developing and assessing strategies to enhance processes for the clinical document TMF.
• Capable of identifying, understanding, and mitigating risks, while ensuring effective communication of these risks to clinical leadership.
• Previous experience actively supporting audits and regulatory inspections is a plus.
• Experience in oversight and management of vendors.
• Knowledge of reporting tools used to compile standard clinical trial metrics as well as generate ad-hoc reporting.
• Understanding of clinical trial phases involved in drug development and corresponding document requirements.
• Demonstrates flexibility in working in a matrix environment.
• Ability to contribute as a study team member and to also interact within a global, cross-functional team matrix.
• Familiarity with industry workgroups and initiatives such as CDISC TMF Reference Model (formerly DIA TMF Reference Model).
• Excellent written and oral communication skills and strong interpersonal skills
• Possesses time management and organizational skills.
• Commitment to producing high-quality work with attention to detail.
• Demonstrated ability to solve problems, critically think, and/or to appropriately seek support as needed.

Desirable

• Prior experience with Veeva Vault eTMF and/or other Veeva products is highly desirable.
• Experience implementing inspection readiness processes and tools.
• Additional knowledge of and experience with regulatory requirements (BLA/MAA submissions) and quality systems preferred.
• Experience with vendor oversight.

Education & Qualifications

• BA or Bachelor of Science, in science related field (biological science, medical, pharmacy or other health related discipline), or equivalent clinical research (or related) experience.
• At least 5 years relevant clinical research (or related) experience in a biotechnology/ pharmaceutical industry and/or clinical research organization in Trial Master File/Clinical Document Management.
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (such as but not limited to Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat) and TMF and/or Document Management applications (e.g., eTMF)

Benefits

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

Equal Opportunity Employment

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 employment relationship with all 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.

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