Manager,Biomarker Operations Job Cambridge area,Massachusetts USA,IT/Tech

The Role

Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials as well as with external biorepositories, assay laboratories and CROs. This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by Moderna.

The Role

Here’s What You’ll Do

Independently support for implementation of clinical biomarker sample management plans and deliverables in Moderna clinical trials
Lead the review of biomarker sections of clinical protocols, lab manuals and consent forms
Lead central lab database specification finalization, including clinical sample kit development, sample storage, sample shipment, sample testing and reporting.
Track and manage clinical sample lifecycle processes from sample collection to long term storage
Monitor clinical sample quality issues and implement issue resolutions
Support clinical teams to ensure biosample usage is compliant with informed consent and GCP/ICH requirements.
Participate in clinical assay vendor oversight, by attending meetings, addressing sample issues, and requesting sample shipments
Promote process improvements for clinical sample lifecycle
Lead the development of processes and procedures for standardized language, biomarker usage, and data reporting

Here’s What You’ll Need (Basic Qualifications)

Bachelor’s degree in a life science-based subject; advanced degree preferred
Minimum of 5 years of clinical research experience which must include sponsor experience
Direct experience with clinical sample management
Familiarity with Excel is essential
Solid understanding of GCP/ICH is required
Strong communication skills and attention to detail
Demonstrated ability to multitask

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.

That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

Competitive healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras

The salary range for this role is $ - $. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a…

Manager, Biomarker Operations