Associate / Director, Clinical Data Management

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
July 18 2019
Ref
R1749
Discipline
Life Sciences, Biology
Organization Type
Biotech
Associate / Director, Clinical Data Management

The Role:

Reporting to the Head of Clinical Data Management, the Associate/Director, Clinical Data Management will be responsible for leading the data management processes for the Rare Disease therapeutic area at Moderna.

Here's What You'll Do:
  • Lead the data management partnership with CROs for studies in the Rare Disease therapeutic area
  • Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
  • Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
  • Perform thorough development testing of the eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable
  • Implement, track and review key performance indicators on data management activity across the Rare Disease program
  • Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements
  • Participate in the Data Standards Committee and act as the liaison between the study team members Rare Diseases to standardize data collection and reporting


Here's What You'll Bring to the Table:
  • Master's or bachelor's degree in computer science or a science-based subject with at least 10 years of clinical data management experience in industry, with experience across indications and EDC platforms (or Doctorate with at least 5 years of experience in industry); or a bachelor's degree outside of computer science or a science-based subject with a minimum of 12 years of clinical data management experience in industry, with experience across indications and EDC platforms
  • At least 3 years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas
  • Vendor management and oversight experience
  • Strong technical skills across data platforms
  • Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
  • Cross collaboration proficiency with other departmental functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
  • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
  • Experience in regulatory GCP inspections/audits
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Ability to manage multiple projects in a fast-paced environment
  • Creative, capable problem-solver


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.

Similar jobs

Similar jobs