Trial Master File (TMF) Manager

Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies.

We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.

We are located in the San Francisco bay area, in the heart of the world’s largest biotechnology research hub.

Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants.

Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer.

Job Summary: Responsible for overseeing all clinical document quality/control/filing, including the Trial Master Files (e/TMFs).

Maintain Arcus’ TMFs ensuring they are current and inspection-ready for internal and external reviews.

Lead and advise on clinical document activities and establish/maintain the area’s direction to ensure systems and procedures are current and compliant with industry and regulatory standards.

This position supervises the clinical documentation control process and is responsible for the training of Arcus staff.

Responsibilities also extend to providing guidance and management/filing of documents in the e/TMF from other functional areas, as appropriate.

Job Responsibilities: Provide support and training to staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines Oversee management of internal e/TMF applications and associated processes Oversee management of CROs’ e/TMF applications Functional lead for specified e/TMF platform with vendor(s) Provides technical system support, including management of helpdesk tickets, as required As functional project lead, provide updates at team meetings and oversee document management timelines, as delegated Manage eTMF vendor(s) to include regular and frequent telephone contact and face-to-face meetings as required Oversee and ensure training of clinical document management staff Represent the clinical document management function both internally and externally, when applicable Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions Support the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate Create and maintain written instructions, guidelines and plans as they relate to e/TMFs and document control Establish and maintain Naming and Filing Guide(s) for relevant e/TMF systems Conduct or oversee training of internal and external e/TMF users Track and provide metrics to Clinical Operations Management to support vendor governance activities Support inspection/audit activities Work in collaboration with all applicable functional areas Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate Manage delivery of e/TMF to Arcus if e/TMF is maintained externally Assist Clinical Operations Management in any additional initiatives, as required Qualifications: Minimum education and experience level Bachelor’s degree or equivalent combination of education/experience in science or health-related field Minimum 6 years of supervisory e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization Experience with assessing, selecting and overseeing the management of e/TMFs and associated data migrations and archiving CRO/TMF/document services vendor management experience Thorough knowledge of eTMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals Thorough knowledge of all sections of the DIA Reference Model (current version) Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements Thorough knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles Proficiency in developing and delivering educational materials, both written and oral Ability to engage in cross-functional interactions with internal and external partners Global trial experience Strong verbal and written communications skills, as well as problem-solving skills Preferred qualifications Veeva Vault experience, particularly as a Veeva Business Administrator Clinical document control, management and e/TMF supervisory experience for a pharmaceutical, biotechnology company, or contract research organization