Clinical Trial Manager (Rare Disease or Infectious Disease), Clinical Operations

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
May 17 2019
Ref
R1649
Discipline
Life Sciences, Biology
Organization Type
Biotech
Clinical Trial Manager (Rare Disease or Infectious Disease), Clinical Operations

The Role:

The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Clinical Operations Leader in the assigned Therapeutic Area.This role maywork collaborativelyon one trial or across several trials to support clinical operations activities.

Here's What You'll Do:
  • Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial
  • Communication to internal team members on deliverables and ensuring timelines are met
  • Manage trial feasibility process
  • Work closely with Rare Disease or Infectious Disease Clinical Operations Strategy Leader to implement Operations plan for Clinical Study Teams.
  • Drafting site materials including training, manuals and support documentation
  • Monitoring of clinical data to ensure timely entry and readiness for data review meetings
  • Periodic review of clinical data
  • Review of clinical monitoring reports to ensure timely completion and identification of issues
  • Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
  • Maintain trial metrics
  • Ensure trial is conducted in accordance to Moderna and ICH/GCP standards including multiple regions in global trials
  • Support the CRO in testing clinical trial systems/databases (i.e. UAT)
  • Develop and maintain strong, collaborative relationships with key stakeholders within Moderna


Here's What You'll Bring to the Table:
  • At least 5 five years of trial coordination experience in a clinical research environment, some should be in industry
  • Advanced degree preferred or Bachelor's in a science-based subject
  • Relevant therapeutic experience in global setting
  • Solid understanding of drug development
  • Good project management skills
  • Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  • Excellent verbal and written communication skills
  • Good organizational skills and attention to detail


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


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.

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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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