Trial Master File Specialist

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

The Trial Master File Specialist will work proactively and collaboratively with our clinical research teams, Clinical Quality, and other collaborating teams to ensure the successful delivery of high-quality Trial Master File (TMF). 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 812, ISO 14155, EMA Clinical Trials Directives), and Apple Standard Operating Procedures (SOPs) as appropriate. The TMF Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the clinical research teams to ensure that the TMF is kept both current and inspection ready.

Primary Responsibilities

• Implement GCP compliant TMF Management program
• Implement risk-based approach for TMF Quality Reviews per ICH Guidelines
• Provide eTMF system training for end users and manage user accounts.
• Support change control management and impact assessments of eTMF System releases
• Work directly with TMF Content Owners to identify issues and perform completeness checks.
• Act as TMF subject matter expert (SME) for study teams and TMF stakeholders
• Perform QC and maintenance of eTMF, manage EDLs
• Conduct TMF audits
• Reconcile essential documents to avoid duplication
• 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
• 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
• Develop metrics, reports, and TMF tools/trainings
• Identify trends that could improve the quality of clinical studies and data collection processes.
  
  

Additional Responsibilities

• Performs other related duties and assignments as required
  
  

Qualifications

• Experience with Veeva Vault eTMF.
• Familiarity with international clinical trials highly desirable
• 3-5 years of experience working in an FDA regulated environment supporting essential regulatory document collection.
• Demonstrated experience or knowledge with sponsor or CRO clinical research processes, 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 study conduct procedures, together with an understanding of GCP guidelines
• Experience with electronic trial master file system(s) including uploading, reviewing, quality checks (QC), and approval of essential TMF documents.
• Working knowledge of the DIA reference model.
• Excellent attention to detail, sound judgment, and ability to work independently.
• Strong communication skills and ability to create a clear sense of direction is necessary.
• Ability to prioritize tasks and deliver assignments with high quality in a timely manner.
• Strong interpersonal skills; Ability to build strong relationships and positively motivate others.
• Ability to understand clinical quality assurance processes including, but not limited to, planning and conduct of Sponsor and vendor TMF audits, Good Clinical Practices (GCP), Good Documentation Practices (GDP), and Document Management Systems is required.
• Detail oriented, excellent organizational and management skills.
  
  

Education & Certifications

• Bachelor’s Degree or equivalent combination of education/experience in math, science, life sciences, pharmaceutical, or health related field required.
  
  

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
  
  

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 50.00 - 70.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers