(Contract) Sr. Clinical Data Manager

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
April 12 2019
Ref
R1576
Discipline
Life Sciences, Biology
Organization Type
Biotech
(Contract) Sr. Clinical Data Manager

The Role:

Moderna is seeking a Senior Clinical Data Management Consultant to lead the Data Management activities for both Oncology and Rare Disease programs. This position will initiate best practices and lead clinical data management initiatives across the ventures as well as support the oversight of data management vendors and data handling. This role will report to the Head of Clinical Data Management at Moderna. The anticipated time frame for this assignment is 12 months.

Here's What You'll Do:
  • Enables achievement of major data management deliverables and data milestones for oncology and rare disease programs in coordination with other functions including Medical, Clinical Operations, Pharmacovigilance, Biostatistics and Statistical Programming
  • Responsible for the quality of the data in each clinical database, as well as quality of other data management deliverables
  • Consult with CROs to solve operational data issues
  • Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
  • Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements
  • Ensure timing and integrity of data transfers from all vendors
  • Review data analysis listings and report on performance and quality
  • Review clinical data within studies and across for trend analysis
  • Support the strategy for data cleaning to ensure timely deliverables
  • Support the data collection through efficient eCRF and database design; ensure thorough UAT requirements for database and test according to UAT Plan.
  • Ensures documentation and archival of data management deliverables
  • Maximizes intra- and inter-project standardization and sharing of best practices.
  • Serves as a member of Clinical Study Teams and acts and primary Data Management contact and contributor for assigned projects
  • Review and provide feedback on protocols, Statistical Analysis Plans, etc.


Here's What You'll Bring to the Table:
  • Bachelor's Degree in a science-based subject expertise.
  • At least 10 years of clinical data management experience in industry, with experience with Medidata Rave┬« and experience with JReview┬« reporting software
  • Early and late development experience; experience with oncology indications is a must
  • Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc.
  • Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
  • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Creative, capable problem-solver


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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