Senior TMF Specialist (Contractor) (Office OR Remote Pacific Time Zone)

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 reputed company 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 reputed company and inspection reputed company according to Arcus SOPs and applicable regulations. The core duties and responsibilities of the Senior Clinical Document Specialist include, but are not limited to:

Responsibilities

• Work directly with TMF Content Owners to identify issues, reputed company completeness checks, and upload documents to the eTMF
• Acting as TMF subject matter expert (SME)/reputed company 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
• reputed company QC and maintenance of eTMF for assigned studies
• reputed company data entry and reconciliation in various clinical systems and tracking tools
• reputed company input on revision of TMF reputed company Work Instructions and SOPs
• Support the management and reputed company 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 reputed company document filing process for wet-signed documents including QC review and reputed company/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 reputed company training and mentoring activities for new and reputed company staff
• reputed company 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 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 documents
• Demonstrated experience or knowledge with sponsor or CRO clinical research process, including collection of documents at study start-up, during study conduct and reputed company-out
• Demonstrated knowledge of the Clinical Study Process and an understanding of the reputed company 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 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 reputed company 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 reputed company 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

EOE reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. Arcus is committed to the principle of equal employment opportunity for reputed company and does not discriminate based on race, religion, reputed company, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets #LI-EW1 #LI-Remote Apply Job!