Job Title

OverviewDescription 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.ResponsibilitiesWork directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMFActing as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLsReview and classify documents collected from internal and external sourcesReconcile essential documents to avoid duplicationSupport study teams with the TMF quality review processPerform QC and maintenance of eTMF for assigned studiesPerform data entry and reconciliation in various clinical systems and tracking toolsProvide input on revision of TMF related Work Instructions and SOPsSupport the management and oversight of the CRO study-specific trial master filesSupport the coordination of the transfer of study-specific trial master files from the CROFollow up on quality findingsManage paper document filing process for wet-signed documents including QC review and paper/electronic filingParticipation in audit, inspection readiness preparation and inspection activities as neededWork cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMFMay provide training and mentoring activities for new and current staffDevelop metrics, reports, and TMF tools/trainingsAct as stand-in leading team meetings, managing team tasks as neededPosition may require occasional travelQualifications (including Knowledge & Skills)Bachelors or Associates degree and a minimum of 4 - 6 years of professional clinical trial experience OR a high school diploma and a minimum of 6 years of clinical support experience with essential regulatory documentsDemonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and close-outDemonstrated 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 guidelinesFamiliarity with international clinical trials, clinical trial documents and document QC process highly desirableExperience with Veeva Vault electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required documentsWorking knowledge of DIA reference modelWorks under general supervision and guidance. Works with manager to establish priorities and timelinesStrong computer skills (MS Office) including exposure to data/document management systemsMust be able to work quickly, prioritize effectively, and show attention to detailGood communication and interpersonal skillsGood time management skills, excellent attention to detail, and ability to multi-task in a high-volume environmentTeam oriented and flexible; maintaining integrity and high ethical standardsAbility to build strong relationships with co-workers of various backgrounds and expertiseAbility to function at a high level in a team setting whether as group contribution or acting as an individual contributorEOEArcus 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 #J-18808-Ljbffr