Sr. / Manager, Clinical Data Management

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
July 18 2019
Ref
R1750
Discipline
Life Sciences, Biology
Organization Type
Biotech
Sr. / Manager, Clinical Data Management

The Role:

Moderna is seeking a Manager/Senior Manager, Clinical Data Management to work across its 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 Senior Director, Clinical Data Management at Moderna

Here's What You'll Do:
  • Perform data management oversight activities in support of Moderna clinical studies; oversee the activities of CRO DM counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance to quality
  • 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 development of all Data Management documentation including the Data Management Plan, CRF Completion Guidelines, Data Validation Specification, Data Transfer Specifications, etc.
  • Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements
  • Review data analysis listings and report on performance and quality; review clinical data within studies and across for trend analysis
  • Perform thorough development testing of the eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable
  • 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:
  • Bachelor's Degree in a science-based subject expertise.
  • At least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms
  • Early and late development experience
  • 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


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