Temp - Trial Master File (TMF) Lead
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Collaborates with the clinical study team to set up, manage and oversee the study trial master file (TMF). Creates and maintains the TMF plan and the study specific inventory list. Advise the study team about the status of the TMF (completeness, quality and timeliness) and ensures the completion and resolution of the periodic quality reviews. Responsible for locking the TMF at the end of the study following approval by all functional areas.
• Serve as the steward of the study eTMF to make sure the process to ensure completeness, quality and timeliness is followed by the study team.
• Effectively communicate and drive document management compliance and quality issues to the clinical study teams and management.
• Present eTMF at study Kick-off meeting and investigator meetings (CRA training) and attend regular study team meetings as applicable to report on the status of the TMF
• Support the clinical study teams to ensure study TMFs are submission and inspection ready at all times.
• Prepare the study specific TMF plan and corresponding study inventory list and insure they are current throughout the study and finalized at study completion.
• Conduct documentation reviews of the TMF looking for areas missing significant documentation, logical checks (missing versions, missing documentation from 1572 participants, correct number of sites, etc), gross errors in location, inconsistencies in naming conventions.
• Ensure QC reviews are conducted as prescribed in the TMF plan and that issues identified are addressed
• Support the study team during inspections and audits as necessary.
• Manage deletion/demotion requests throughout the duration of the study (Once Veeva eTMF workflow is in place)
• Answer any filing queries or general Veeva eTMF questions from CRO/study team
• Ensure Veeva eTMF is set up for the study and that countries and sites are added as needed.
• A demonstrated, deep understanding of the TMF Reference model and processing of documentation into the eTMF system.
• Ability to create the TMF plan and ensure compliance by the study team
• Demonstrated ability to prioritize and manage multiple projects simultaneously
• Demonstrated ability to work effectively with many different types of personalities at all levels of the organization
• Excellent interpersonal, collaboration and stakeholder management skills
• Excellent communication skills (written/verbal)
• Highly self-motivated, flexible, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure
• Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
• Highly proactive, flexible, curious and resilient
• Proficient in Microsoft Applications; Word, Excel, Project, and PowerPoint
• Ability to travel ( • Bachelor's degree or equivalent and 3 years of experience
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Requisition Number: 13273BR