(Contract) Trial Master File Administrator, Clinical Operations

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
March 22 2019
Ref
R1529
Discipline
Life Sciences, Biology
Organization Type
Biotech
(Contract) Trial Master File Administrator, Clinical Operations

The Role:

Moderna is seeking a Trial Master Administrator to work across its projects as well as to work with the eTMF vendor and CROs. This position reports directly to the Moderna's Head of Therapeutic Operations. This position will work collaboratively across several therapeutic area teams for to ensure implementation, compliance and support of the eTMF for clinical trials conducted by Moderna.The anticipated time frame for this role is 3 months.

Here's What You'll Do:
  • Participate in study team meetings and provide an overview of TMF status
  • Set up eTMF for each clinical study and ensure ongoing compliance
  • Develop and maintain system access rights and permissions
  • Collaborate with internal and external team members to support implementation, on-going use and optimization of the eTMF and any additional new platforms in the future
  • Provide internal communication of system access, training, updates and ongoing maintenance
  • Participate in departmental initiatives aimed at improving process, efficiency and optimization of processes to the overall benefit of the Clinical Operations
  • Responsible for maintaining Sponsor file readiness at all times for inspection by health authorities
  • Ensure file readiness and provide technical support in preparation for site and incoming (including internal) audits.
  • Ability to transition CRO TMF to the Moderna system and access for completeness
  • Conduct targeted eTMF quality checks and audits as needed for ongoing studies
  • May be involved in other tasks to support Clinical R&D Operations and Franchise Clinical R&D, as needed.


Here's What You'll bring to the Table:
  • Bachelor's degree in a science-based subject
  • Minimum of 3 years of clinical research experience which must include TMF management
  • Solid understanding of good Clinical GCP/ICH is required.
  • Creative, capable problem-solver
  • Experience in establishing and maintaining relationships with vendors


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.

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

#LI-DNI

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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