Manager, Clinical Document Management

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.

Position: Manager of Clinical Document Management 

Reports to: Director, Clinical Document Management and Inspection Readiness 

Job Responsibilities:

Position Overview: 

The Manager of Clinical Document Management will support the cross-functional study team and the Larimar Clinical Document Management and Inspection Readiness 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 and national 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. 
• Ad hoc support for review study plans, as requested 
• Supporting the Associate Director of Clinical Document Management and Inspection Readiness with the management of Veeva and functional system releases, as needed 
• Support with the oversight and management of vendors supporting the Clinical Document Management team with document filing and document-level QC
• Oversight of eTMF system-related process and workflows and support integration efforts with eTMF and the other modules as needed 
• 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
• Support with eTMF validation processes such as execution of UAT/PQ and development/review of validation documentation
• 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 Clinical Document Management and Inspection Readiness related deliverables as needed

Requirements

Qualifications:

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:

• Prior experience in clinical operations and/or clinical quality 
• Pharmaceutical or biotechnology experience preferred 
• Experience with Veeva’s Vault platform and/or the Veeva Vault eTMF 

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.