(Contract) Sr. Specialist, Clinical Systems

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
June 28 2019
Ref
R1626
Discipline
Life Sciences, Biology
Organization Type
Biotech
(Contract) Sr. Specialist, Clinical Systems

The Role:

Moderna is seeking a Clinical Systems Administrator to lead the User and Site Account Administration within all clinical systems across the clinical platform at Moderna. This position will initiate best practices and processes related to user and site account management. This role will report to the Senior Director of Clinical Data Management at Moderna. The anticipated time frame for this assignment is 12 months.

Here's What You'll Do:
  • Perform activities related User and Site Account Administration and Maintenance within all clinical systems across the clinical platforms for internal and external stakeholders
  • Perform Clinical System Account Creation/management, Issue resolution, process improvement, enhancements, validation and migration improvement
  • Lead/perform clinical information system administration including the definition of best practices and SOPs; creation of SOPs, best practices, training, global work streams related to user account requests, administration and management
  • Work across the Moderna portfolio with the Clinical Study Teams to manage Moderna clinical system reporting; perform as primary liaison for both standard recurrent reports, as well as ad hoc report requests
  • Development and utilization of reports across the clinical systems, identification of efficiencies in ongoing review, trend identification and development of best practices and data flow solutions
  • Ensures effective communication and issue escalation internally and with external vendors
  • Collaborates with clinical development and informatics contributors to define and support clinical system roadmap. Ensures harmonized user and site administrative account management and support across all clinical systems


Here's What You'll Bring to the Table:
  • Bachelors Science Degree in Computer Science, Bioinformatics, Business Information systems or in a relevant technical field or equivalent technical experience
  • 5+ years of Clinical Information System management experience including systems such as EDC, IRT and eTMF experience
  • Experience managing Clinical Information System vendors
  • Prior experience working with multiple Clinical Information Systems simultaneously
  • Knowledge of relational databases (e.g., Medidata Rave®, iMedidata®) and experience with JReview® reporting software is strongly preferred
  • General knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines
  • Detailed knowledge of FDA CFR Part 11 regulations
  • Good organization and project management skills with a demonstrated ability to work independently, take initiative, complete tasks to deadlines.
  • Requires strong attention to detail, document organization skills and scheduling
  • Excellent communication skills and strong customer focus with ability to interact in a cross functional organization and team environment
  • Ability to communicate effectively with external vendors, including issue escalation, and responding to inquiries and concerns
  • Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks
  • Advanced computer proficiency
  • Demonstrated ability to be flexible and to adapt quickly to change a high degree of initiative, commitment and persistence


Why join Moderna Therapeutics

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-DNI

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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