Sr Manager, TMF Quality Oversight

2 months ago

Cambridge, United States Moderna, Inc. Full time

The Role:
The Clinical Trial Systems Operations (CTSO) team within Clinical Trial Excellence and Support at Moderna is looking for an agile, self-motivated, and experienced team leader to work across clinical trials to conduct quality reviews of trial master files (TMF) and related documentation to help ensure TMFs meet regulatory standards and meet Modernas requirements for trial oversight (e.g. audit), and external inspection, at all times. The successful candidate will be detail-oriented with a flexible and solution-oriented outlook with the ability to support team members within Moderna and with our CRO partners.

Heres What Youll Do:

Functional Team Manager

Manage team of TMF Quality Review Associates that perform periodic completeness reviews of trial TMF content for quality and completeness.

Ensure assigned periodic reviews are scheduled and conducted per trial TMF Plans.

Review teams work for quality, and address gaps with remediation such as new training, tools etc.

Provide performance feedback as needed on functional service provider team members.

Collaborate with peers in CTSO to ensure consistent execution for periodic completeness reviews across the trial portfolio.

Work closely with the Associate Director, Clinical Records Management to understand requirements for periodic completeness review activities. Contribute ideas for enhancement of process and tools.

Contribute directly to periodic completeness reviews to ensure first-hand knowledge application of process and tools.

Sit in the CTSO leadership team and attend departmental and trial-specific meetings and discussions, as required.

Complete other TMF document-related tasks as required by the Director, Clinical Trial Systems Operations.

Heres What Youll Bring to the Table:

BA/BS required.

6+ years of experiencein a clinical research environment within the pharmaceutical and biotech industry.

4+ years TMF document management experience, preferably with TMF completeness and quality oversight experience.

Previous experience managing a team is an advantage.

Clear and timelycommunication skills.

Proficiency with clinical research documents, their contents, and purpose

Knowledge of ICH/GCP guidelines and other applicable regulatory rules and guidelines.

Strong organizational/prioritization skills for the management ofworkloadand attention to detail

Demonstrated proficiency with eTMF applications.

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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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