Senior Manager, Clinical Document Management And Clinical Inspection Readiness

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Description

The Company:

This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, 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 has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has about 45 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 (GMPs).

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 and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position Purpose and Description

The Sr. Manager of Clinical Document Management and Inspection Readiness will provide support for Trial Master File (TMF) and inspection readiness (IR) activities to the Clinical Document Management team and to internal and external clinical study team members and functional areas.

Reporting Relationships

• Reports to: Associate Director, Clinical Document Management (Statistics and Quantitative Sciences)

• Direct reports: None - some oversight of contractors/consultants, as needed

• Interacts with: Cross-functional clinical study teams and relevant functional areas, Information Technology, Quality, external vendors including eTMF system vendor, Veeva

Primary Responsibilities

• Assist with the development, implementation, management, and continuous improvement of TMF and Inspection Readiness business processes (e.g., SOPs, WIs) that meet Larimar's cross-functional business needs, all applicable national and local regulatory requirements (e.g., ICH-GCP, FDA, EMA, MHRA, etc.), and are aligned with industry standards and best practices (e.g., CDISC).

• Assist with the development, implementation, management, and continuous improvement of tools and materials to support Clinical Document Management and Inspection Readiness, including tracking tools, quick reference cards, tipsheets, and training and/or reference materials.

• Serve as TMF SME to clinical study teams, providing guidance and support with TMF and clinical study documentation processes and best practices, including developing and administering TMF/eTMF training materials and resources (e.g., SOP training, system training, TMF process training such as Quality Review and related workflows, and management of Expected Document Lists (EDLs).

• Assist with the management and maintenance of the electronic Trial Master File (eTMF) system and in supporting or leading systems integration efforts with systems that interface with the eTMF, for example, regulatory (e.g., RIM), and quality systems (e.g., QMS).

• Assist with establishing and participating in TMF governance meetings with clinical study vendors and/or eTMF vendors

• Working with cross-functional business units to ensure that the eTMF system supports the needs of the business while remaining in compliance with all applicable regulatory requirements.

• Support of various eTMF-related oversight activities including system training, IT change control/change management processes, administrative management of system processes and system data such as audit trails, access logs, and reports, and communication to end users on system-related issues and updates, including configuration changes.

• Development and review of study specific TMF Plans (including other TMF Plans as applicable, for example Migration, Oversight, or Governance plans) and TMF Indexes and training to internal and external team members on study specific TMF processes, including for example TMF business process, TMF quality review, management of expected documents and lists, and reports and dashboards.

• Oversight of study specific TMFs and compliance with study specific processes as it relates to clinical study documentation.

• Support with IT change management activities including development, review, and/or execution of computer system validation (CSV) deliverables such as performance qualification (PQ)/user acceptance testing (UAT) test scripts, migration plans, PQ/UAT plans, etc.

• Provide systems support for the eTMF including but not limited to providing system training and support to internal and external study-team users, creating and maintaining resources to support with eTMF processes, managing eTMF access, setting up and managing clinical data in the eTMF, supporting eTMF process improvement including supporting change management related to eTMF configuration.

• Supporting clinical study teams with inspection readiness efforts as they relate to TMF and clinical documentation, including conducting or supporting with ongoing and periodic TMF and document reviews/gap assessments, and the development and management of tools to assist with study tracking and inspection readiness and execution (e.g., BIMO checklists, SOP logs, etc.).

• Supporting clinical study team members with the completion of inspection readiness deliverables including checklists, tracking tools, and storyboards.

• Participate in the development, review, and implementation of processes related to inspection management and supporting regulatory inspections, as needed.

• Ad hoc support of other clinical document management and inspection readiness related deliverables as needed.

Requirements

• Bachelor's Degree

• 8+ years clinical research experience within the pharmaceutical/biotechnology industry, preferably within sponsor organizations

• Experienced with document management and/or electronic trial master file systems (eTMF), for example, Wingspan, Documentum, Trial Interactive, Veeva Vault, etc.

• Experienced in the set up and maintenance Trial Master File and thorough understanding of relevant regulatory requirements as they relate to both the TMF and clinical study conduct.

• Thorough understanding of the CDISC (formerly DIA) TMF Reference Model

• Prior experience preparing for and supporting audits and regulatory inspections (actual or mock)

• Experience in developing and administering training and training/support materials

• Ability to manage multiple projects with competing priorities

Preferred

• Master's Degree and/or trainings/certifications in a relevant area

• Experience in areas outside of TMF operations including clinical operations, clinical quality, and/or clinical compliance

• Experience with managing and overseeing vendors

• Experience with Veeva Vault

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.