TheAssociate Director, TMF Records Management is an operations role within the Clinical Trial Systems Operations team that is part of Clinical Trial Excellence and Support at Moderna. The Associate Director, TMF Records Management is an agile,self-motivated, andexperiencedleader responsible for ensuring Moderna study TMFs (trial master files) are set up and maintained to meet all regulatory requirements and according to Moderna policies and industry best practices. The Associate Director, TMF Records Management will also be responsible for sharing subject matter expertise in clinical records management with Moderna and CRO partner clinical trial teams (CTT), and TMF support teams.
Heres What Youll Do:
Hire, manage and develop a team of eTMF Managers that set up and maintain study electronic Trial Master Files (eTMFs) for CTTs at Moderna, to ensure that trial eTMFs are always inspection ready.
Own governance of the TMF structure and content, working with representatives of all clinical development functions.
Includes ownership of the eTMF file configuration and the maintenance of controlled documents used in TMF management, including SOPs, Work Instructions, templates, and forms.
Set requirements for TMF oversight activities including:
Timing and scope of periodic document reviews.
Use of relevant eTMF system features (e.g. expected document lists)
Quality and completeness metrics at study and portfolio levels.
Collaborate with the AD, Clinical Systems Operations and Support:
Resolving system, quality, or other issues.
Ensuring activities performed by the 3rd party TMF services vendor meet requirements, including escalating performance or delivery issues.
Ensuring TMF Manager and specialists roles align and complement each other and operate effectively on Moderna trials.
Provide expert analysis of portfolio TMF quality and completeness metrics and provide recommended actions to Clinical Development Operations leadership and alliance partnership leads.
Act as eTMF Manager on a part-time basis to ensure first-hand knowledge of application of process and tools.
Provide training and support to end users on TMF filing best practices.
Lead process improvement initiatives as assigned.
Escalate system, quality or other issues to the Director, Clinical Trial Systems and Operations or VP, Clinical Trial Excellence and Support as appropriate and in a timely manner.
Heres What Youll Bring to the Table:
8+ years working in pharmaceutical clinical research.
6+ years of experienceworking in clinical records management, preferably in eTMF teams in a sponsor or CRO setting.
Previous experience managing a team is an advantage.
Skilled in clear and timelycommunication.
Demonstrable knowledge ofGCP andrelated regulatory requirements.
Strong organizational/prioritization skills for the management ofworkloadand attention to detail.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at firstname.lastname@example.org. (EEO/AAP Employer)