This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate. The Senior Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to Arcus SOPs and applicable regulations.
Responsibilities- Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
- Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs
- Review and classify documents collected from internal and external sources
- Reconcile essential documents to avoid duplication
- Support study teams with the TMF quality review process
- Perform QC and maintenance of eTMF for assigned studies
- Perform data entry and reconciliation in various clinical systems and tracking tools
- Provide input on revision of TMF related Work Instructions and SOPs
- Support the management and oversight of the CRO study-specific trial master files
- Support the coordination of the transfer of study-specific trial master files from the CRO
- Follow up on quality findings
- Manage paper document filing process for wet-signed documents including QC review and paper/electronic filing.
- Participation in audit, inspection readiness preparation and inspection activities as needed
- Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF
- May provide training and mentoring activities for new and current staff
- Develop metrics, reports, and TMF tools/trainings
- Act as stand-in leading team meetings, managing team tasks as needed
- Position may require occasional travel
Qualifications- Bachelors or Associates degree and 4+ years of professional clinical trial experience OR a high school diploma and 6+ years of clinical support experience with essential regulatory documents
- Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-out
- Demonstrated knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
- Familiarity with international clinical trials, clinical trial documents and document QC process highly desirable
- Experience with Veeva Vault electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required documents.
- Working knowledge of DIA reference model
- Works under general supervision and guidance. Works with manager to establish priorities and timelines
- Strong computer skills (MS Office) including exposure to data/document management systems
- Must be able to work quickly, prioritize effectively, and show attention to detail
- Good communication and interpersonal skills
- Good time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment
- Team oriented and flexible; maintaining integrity and high ethical standards
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether as group contribution or acting as an individual contributor
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 $115,000- $125,000 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 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.
EOE
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
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