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(Contract) Clinical Trial Manager

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Closing date
Feb 26, 2020

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Discipline
Life Sciences, Biology
Job Type
Research Scientist
Organization Type
All Industry, Biotech

Job Details

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. The anticipated time frame for this assignment is 4 months.

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
  • 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


Why join Moderna:

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

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 named a top employer by Science for the fifth year in a row. 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.

Company

Moderna is a clinical stage pioneer of messenger RNA (mRNA) Therapeutics™, an entirely new in vivo drug technology that directs the body’s cells to produces human proteins, antibodies and novel protein constructs, which are in turn secreted or active intracellularly. Founded in 2011, we are headquartered in Cambridge, Mass. 

Our Team and Mission

We currently have over 500 team members, an exceptional group of scientists and industry professionals who are wholly committed to advancing Moderna’s mission:  deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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