Trial Master File Specialist

Kelly Science is looking for great candidate to support biotech pharmaceutical as Contract TMF Specialist.

Trial Master File Specialist

Main responsibilities:

Collects, reviews, files, maintains and archives essential regulatory documents for the Trial Master File TMF in accordance with Good Clinical Practice GCP, E6 International Conference on Harmonisation ICH Guidelines and other regulatory guidance documents, relevant regulations e.g., 21 CFR Parts 312 and 314, European Medicines Agency EMA Clinical Trials Directives, and company Standard Operating Procedures SOPs as appropriate.

Essential regulatory documents include, but may not be limited to:

• Externally-sourced documents from clinical investigators, Institutional Review Boards IRBs /ethics committees, competent authorities, etc., and internally-sourced documents e.g., clinical protocol, Data Management Plan [DMP], Statistical Analysis Plan [SAP], etc. for domestic and international clinical studies.
• Works cross-functionally with internal departments and external resources on Clinical Documentation related issues.
• Supports adherence to relevant regulatory requirements and company SOPs as appropriate.

Essential Functions:

• Works with multi-functional teams internal and external to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
• Tracks effective and expiration dates of external documents e.g., clinical laboratory certifications, Medical Licenses, and curriculum vitae [CVs].
• Collects, reviews, and indexes essential documents in accordance with TMF structure.
• Uploads TMF documents into the eDMS and/or other document files, e.g., as working documents while the study is ongoing.
• Acts as TMF Subject Matter Expert SME and point-of-contact for study teams and TMF stakeholders.
• Provides oversight of Contract Research Organization CRO / Vendors when TMF is outsourced.
• Provides support and TMF guidance during audit and/or inspections.
• Performs other tasks and assignments as needed and specified by management.

Skills Required:

• Minimum level of education and years of relevant work experience.
• High school diploma and a minimum of 3 years of relevant professional experience with essential regulatory documents in a pharmaceutical, biotechnology, CRO or related environment.
• Special knowledge or skills needed and/or licenses or certificates required.
• Thorough knowledge of essential regulatory documents required for the conduct of clinical studies, as described in the ICH E6 Guidelines and in relevant regulations e.g., Food and Drug Administration FDA 21 CFR.
• Knowledge and working experience with TMF Reference Model.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Special knowledge or skills and/or licenses or certificates preferred.
• Associate's and/or Bachelor s degree.
• Experience using eDMS software.
• Demonstrated experience identifying, developing, and implementing improvements to departmental processes that increase efficiency and that maintain or improve quality e.g., increasing the numbers of documents processed.
• Demonstrated ability to identify opportunities to improve study sites processing of essential regulatory documents.
• This includes communicating recommended changes to the sponsor's study management and site monitoring staff.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.