TMF Operations Specialist at American Cybersystems, Inc. in Sacramento, California

TMF Operations Specialist

A client of Innova Solutions is immediately hiring for a TMF Operations Specialist. Position type: Full-time- Contract Duration: 4 Months Location: Novato California 94949 (HYBRID) As TMF Operations Specialist, you will:

This position is responsible for the maintenance, quality review, transfer, closure, and archival of Sponsor Trial Master File (TMF) essential documentation in accordance with regulatory requirements and principles and standards of Good Clinical Practice (GCP) International Conference on Harmonization Regulations (ICH) E6 (R3), and European Union (EU) regulations/directives, and Client Standard Operating Procedures (SOPs) as appropriate. The TMF Operations Specialist will provide support to the TMF content owners on one or more clinical programs. This position serves as a pivotal point of contact and works closely with internal Study Management Teams (SMTs) and external CROs/Vendors to ensure that the TMF is complete, accurate, contemporaneous, and inspection ready according to Client TMF SOPs and TMF Plans. The core duties and responsibilities of the Clinical Document Specialist include, but are not limited to:

• Perform quality checks of TMF document submissions (uploads) for approval, identify and assign any quality issues (QIs), and follow-up for action completion and QI resolution
• Ensure TMF documentation follows the requirements outlined in study-specific TMF Plans and Indices including but not limited to document classification, expectedness, filing level, naming conventions, metadata assignment, responsibility, filing locations, etc.
• Track periodic and final review intervals and provide TMF full report/inventories for study team review performance; verify review completion and quality issue (QI) resolution and issue TMF periodic and final review completion certificate(s)
• Support TMF final transfer activities for the receipt, review, acceptance, and archival of TMF transfers from external CROs/Vendors
• Attend TMF Operations and SMT meetings regularly and provide updates on SMT TMF performance, status updates, trends in identified quality issues, risk mitigations, and outstanding/open quality issues
• Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps for a study TMF

Requirements:

• This position is remote based, but candidates must reside within the Novato, CA area for ad-hoc on-site visits to the Novato, CA office for receipt, inventory review, and storage of TMF Final Transfers.
• Bachelor's degree or equivalent curriculum (scientific or healthcare discipline preferred) and a minimum of 2 years of professional TMF document control experience.
• Experience with electronic trial master file systems (Veeva Vault eTMF), workflows, configurations, feature/functionality, and industry best practices for business process alignment
• Advanced knowledge of ICH/GCP Regulations, GDP and ALCOA+ requirements, CDISC Reference Model, and industry best practices
• Demonstrated knowledge of Sponsor TMF regulatory requirements and an understanding of the range of working procedures relating to it, together with an understanding of Good Documentation Practices (GDP)
• Familiarity with international clinical trials, clinical trial documents, and document QC process highly desirable
• 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

Pay Range*: $30.00 - $40.00 per hour. Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

About Innova Solutions: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• Named One of America's Best Employers for New Grads by Forbes (2024)
• Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, 2024-2025)
• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
• AWS Advanced Tier Services Partner with 100+ certifications

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at and earn $250-$1,000 per referral.

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.

If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or View phone number on click.appcast.io. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.