Biosample Sr. Specialist, Clinical Operations

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
September 15 2019
Ref
R1756
Discipline
Life Sciences, Biology
Organization Type
Biotech
The Role:

Moderna is seeking a Biosample Sr. Specialist to support the clinical teams and to work across its clinical trials as well as with the external biorepositories, assay laboratories and CROs. This position will report into the Clinical Biomarker and Biosample Group. This position will work collaboratively across all therapeutic area teams for to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by Moderna.

Here's What You'll Do:
  • Provide support to the clinical teams driving agreed upon biomarker sample management for the clinical trials
  • Support the review of the biomarker sections of the clinical protocol, clinical kit development, study/lab manuals and consent forms
  • Manage process for clinical sample lifecycle and biorepository usage
  • Support development of processes and procedures for standardized language, biomarker usage, and data reporting
  • Serve as a point of contact for the biomarker sample repository
  • Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH
  • Oversee clinical assay vendors (routine sample analysis meetings, address sample issues, sample shipments)
  • Troubleshoot sample issues at Central Labs and 3rd-party vendors
  • Contribute to biosample process to help drive continuous improvement


Here's What You'll Bring to the Table:
  • Bachelor's degree in a life science-based subject; Advanced degree preferred
  • Minimum of 3 years of clinical research experience which must include sponsor experience
  • Direct experience with clinical sample management
  • Prior process development experience is very helpful
  • Familiarity with databases is helpful
  • Solid understanding of good Clinical GCP/ICH is required.
  • Strong communication skills and attention to detail
  • Demonstrated ability to multitask


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-KF1

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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