Biology & Biotech (1)

Description

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 plus3+ 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-motivatedand able to work independentlyor 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%.

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.

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

Physical Requirements Office Setting
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.

Senior Manager

Records Management, Clinical Operations

Arcus

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