Summary 

The Senior Manager, Records Management (SMRM), will be responsible for leading activities to support major initiatives across the Records Management Organization.  The SMRM will provide leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality.  Beyond TMF responsibilities, this position oversees reporting, metrics, 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 and report to the head of Business Operations.

Responsibilities

• Responsible for oversight and management of vendors supporting Arcus TMF and associated processes for the TMF
• Lead the development 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 System 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.
• Serve 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 Vendors

Qualifications

• Bachelor’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 independently 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 approximately 10%.