Manager, eTMF (Trial Master File)
The Clinical Operations team at Moderna is looking for an agile, self-motivated, and experienced individual to be responsible for working across teams to implement eTMF strategy, governance, training and maintain documentation related to eTMF across the portfolio. This role will also manage filing and maintenance activities for clinical trials during the study start-up, maintenance and close-out periods. The successful candidate will be detailed oriented with a flexible and solution oriented outlook with the ability to support team members within Moderna and with our CRO partners.
Here's What You'll Do:
Maintains effective communication with project teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance and close-out.
Supports study document filing into the eTMF system
Maintains a naming and filing guide specific to clinical study documents.
Performs routine quality checks of documents uploaded into the eTMF
Responds to inquiries regarding eTMF management and contents.
Attends departmental and study-specific meetings and discussions, as required.
Runs routine TMF reports and monitors for completeness and trends
Provides eTMF training to new team members, both internal and CRO
Performs general administrative tasks.
Completes other study document-related tasks as required by the study teams or the Clinical Operations department
Here's What You'll Bring to the Table:
Life sciences degree or certification in a related allied health profession from an accredited institution (e.g. nursing, medical or laboratory technology) or equivalent
3-5 years experience of clinical trials (e.g., study coordinator, regulatory operations) and of electronic TMF document management experience.
Clear and timely communication skills
Understanding of GCP and regulatory requirements as well as a working knowledge of clinical research documents, their contents and purpose.
Strong organizational/prioritization skills for the management of workload with attention to detail a must
Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes
Here's What We'll Bring to the Table:
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass, or a subsidized commuter rail pass
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale, and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.