Senior Manager, Records Management

Arcus Biosciences • Brisbane, CA

18h • Remote

About The Position

Description Summary The Senior Manager , Records Management ( S MRM) , will be responsible for leading activities to support major initiatives across the Records Management Organization. The ( S MRM) will provide leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalab ility, and quality. Beyond TMF responsibilities, this position oversees reporting , metr ics, KPIs, and analytics that support performance measurement, delivery optimization and continuous improvement. The SMRM will collaborate with the Clinical Operations department , other functional areas , CRO partners, and key stakeholders on TMF processes and systems. This position is remote or if in bay area in-house/hybrid, depending on prior experience . They will report to the head of Business Operations .

Requirements

• Bachelo r’s degree , preferably in a scientific field
• 8 + years of related industry experience at a Sponsor or CRO plus 3 + years of Clinical TMF management is required , ( extensive experience with Veeva Vault and Veeva applications is strongly preferred)
• Previous experience supporting audits and regulatory inspections (e.g., FDA, PMDA, EMA, MHRA).
• Thorough understanding of ICH - GCP guidelines and regulatory requirements as they apply to the TMF .
• Extensive experience in oversight and management of vendors
• Proficient in identifying, understanding, and mitigating risks, while ensuring effective communication of these risks to clinical leadership.
• Demonstrates strong leadership and project management abilities, with flexibility and agility in a multi-functional, global matrix environment.
• Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
• Proficient in developing and writing SOPs .
• Understanding of clinical trial processes and experience in driving execution .
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
• Excellent interpersonal communication and negotiation skills.
• Strong communication skills , both verbal and written , are required (including presentation of materials to internal teams and external partners) .
• Self-motivated and able to work independent ly or as part of a team .
• Demonstrates problem solving and decision- making skills.
• Excellent Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.) .
• Ability and willingness to travel approxim ately 10% .
• Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone.
• This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required.
• Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment.
• Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information.
• Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

Responsibilities

• Responsible for over sight and management of vendor s supporting Arcus TMF and associated processes for the TMF
• Lead the d evelop ment and oversee TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference Model). Partner with subject-matter experts to modify and improve upon existing documents, when required
• Identify, provide recommendations, develop, and lead operational excellence initiatives, including the creation and delivery of tools, processes, templates , training, onboarding , and guidance to drive efficiency, compliance, and best practices, while ensuring quality is integrated into all processes
• Effectively manage resources to ensure appropriately skilled team are assigned to support Records Management Organization, including participating in hiring, training, mentoring and periodically assessing performance during the bi-annual performance review periods.
• Support Records Management inspection-readiness activities
• Create and generate reporting metrics/ KPIs and other analytics that can be used to measure performance, compliance and effectiveness, while ensuring fit for purpose
• Lead interpretation of metrics and analytics to ensure accuracy, interpretation and trends while identifying potential issues, trends, risks, and opportunities
• Participate and support in audits and inspections. Respond and assist in CAPA/process improvements that come from audit(s) and inspection(s)
• Serve as S ystem Business Administrator for Veeva eTMF
• Evaluate Veeva eTMF for system improvements including partnering with IT during system update and User Acceptance Testing activities
• Assist with requests in support of partner operationalized studies.
• Drive ongoing assessment of systems that support
• Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend.
• Build collaborative relationships with key internal and external stakeholders.
• S erve as TMF Operations functional area representative for the implementation of any systems or processes that would interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).
• Lead governance committee with TMF Vend ors

Benefits

• In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package.
• Additional information about our total rewards program can be found here: https://arcusbio.com/careers .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees