The Role: The Clinical Trial Systems Operations (CTSO) team at Moderna is looking for an agile, self-motivated, and experienced individual to be responsible for working across clinical trials to implement and execute on eTMF strategy, governance, and processes, and review/conduct quality checks of eTMFs and related documentation. This role will also manage filing and maintenance activities for clinical trials during the trial start-up, maintenance, and close-out periods. The successful candidate will be detail-oriented with a flexible and solution-oriented outlook and the ability to support team members within Moderna and at our CRO partners.
Here's What You'll Do:
Maintain effective communication with clinical trial teams, CRO staff, and eTMF vendor personnel throughout trial start-up, maintenance, and close-out.
Support TMF document filing into Moderna eTMF system.
Author initial TMF plans and manages updates throughout the trial.
Maintain a naming and filing guide specific to TMF documents.
Perform routine quality checks of documents uploaded into the eTMF.
Respond to inquiries regarding TMF management and contents.
Attend departmental and trial-specific meetings and discussions, as required.
Run routine eTMF reports and monitors TMFs for completeness and trends. Presents analysis and drives actions when identifying issues or negative trends.
Oversee vendor and/or internal TMF operations team members assigned to your trials, escalating performance issues as appropriate.
Where vendor support is used:
Provide input to budget forecasting as required (accruals and trial scope changes).
Provide input to contract provision/amendment as required.
Oversee invoicing on assigned trials.
Support inspection and audit preparation and execution (front and back room as needed)
Support system updates by participating in user acceptance testing and system enhancement discussions.
Complete other TMF document-related tasks as required by the trial teams, your manager or more senior leadership in CTSO or Clinical Development Operations.
Here's What You'll Bring to the Table:
BA/BS required; Advanced degree preferred.
4+ years of experience in a clinical research environment within the pharmaceutical and biotech industry.
2+ years of eTMF document management experience.
Clear and timely communication skills.
Proficiency with clinical research documents, their contents, and purpose, and working knowledge of GCP and regulatory requirements
Strong organizational/prioritization skills for the management of workload and 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 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!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are 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. We're 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)
