SummaryThe 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.ResponsibilitiesResponsible for oversight and management of vendors supporting Arcus TMF and associated processes for the TMFLead 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 requiredIdentify, 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 processesEffectively manage resources to ensure appropriately skilled team are assigned to support Records Management Organization, including participating in mentoring and periodically assessing performance during the bi-annual performance review periodsSupport Records Management inspection-readiness activitiesCreate and generate reporting metrics/KPIs and other analytics that can be used to measure performance, compliance and effectiveness, while ensuring fit for purposeLead interpretation of metrics and analytics to ensure accuracy, interpretation and trends while identifying potential issues, trends, risks, and opportunitiesParticipate 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 eTMFEvaluate Veeva eTMF for system improvements including partnering with IT during system update and User Acceptance Testing activitiesAssist with requests in support of partner operationalized studiesDrive ongoing assessment of systems that supportProvide operational leadership to TMF vendor budget negotiations and management of TMF operations spendBuild collaborative relationships with key internal and external stakeholdersServe 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 VendorsQualificationsBachelor’s degree, preferably in a scientific field8+ 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 TMFExtensive experience in oversight and management of vendorsProficient understanding, and mitigating risks, while ensuring effective communication of these risks to clinical leadershipDemonstrates strong leadership and project management abilities, with flexibility and agility in a multi-functional, global matrix environmentKnowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)Proficient in developing and writing SOPsUnderstanding of clinical trial processes and experience in driving executionAbility to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategyExcellent interpersonal communication and negotiation skillsStrong 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 teamDemonstrates problem solving and decision-making skillsExcellent 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%This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $155,000 - $170,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. 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.Physical Requirements Office SettingMust 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 ore 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 op, 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.
about 2 months ago