eTMF (Trial Master File) System Administrator

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
July 12 2019
Ref
R1742
Discipline
Life Sciences, Biology
Organization Type
Biotech
eTMF (Trial Master File) System Administrator

The Role:

The Clinical Development team at Moderna is looking for an agile, self-motivated, and experienced individual to be responsible for working across teams to implement and administer Moderna's eTMF system across the portfolio. This role will also manage the Moderna configuration, user and permissions access, and reporting 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 the eTMF system from configuration and study set up
  • Maintains a naming guide specific to clinical study documents.
  • Responds to inquiries regarding eTMF access and systems permissions
  • Attends departmental and study-specific meetings and discussions, as required.
  • Runs routine TMF reports for users and permissions
  • 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
  • Free annual corporate membership to Bluebikes
  • 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
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 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 (includes 2 floating holidays)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-FC1

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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.

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