Sr. Manager, Clinical & Biomarker Data Management
ModernaTX, Inc.

Cambridge, Massachusetts

Posted in Science and Research


Job Info


The Role:

The Senior Manager, Clinical & Biomarker Data Management, reporting to the Senior Director, Clinical Data Management, is uniquely situated to support the Clinical Data Management team as well as the Clinical Biomarker team. This role will manage the sample reconciliation and well as data flow and transfers for the entire portfolio of clinical biomarker data, to ensure timely and quality data collection and data reporting throughout the clinical trial lifecycle.

Here's What You'll Do:

  • Collaborate with study teams to oversee CRO/service providers for all clinical biomarker data needs
  • Seek means of improving processes to reduce cycle time, increase accuracy and decrease work effort
  • Manage processes and timelines for clinical biomarker sample reconciliation efforts by CRO to ensure data is cleaned in a timely manner
  • Perform oversight/data review on all clinical biomarker data transfers for Data Management and Clinical Biomarker team
  • Receive, review quality, and organize clinical biomarker data, incorporating information into internal/external databases as needed
  • Coordinate data transfers and data transfer agreements with clinical biomarker team and assay labs as needed
  • Develop and update data transfer specifications through collaboration with clinical biomarker team to ensure consistent data transfers
  • Coordinate data requirements with assay labs to ensure data collection are accurate and formatted appropriately for Data Transfer Specifications
  • Author, manage and track all Data Transfer Specifications for DM and CB
  • Create, execute and/or distribute clinical biomarker data management metrics, listings and reports as required
  • Support development and/or implementation of systems or technologies to support optimizing data flow or data status reporting
  • Improve processes to reduce cycle time, increase accuracy and decrease work effort

Here's What You'll Bring to the Table:
  • BS degree in Life Science, math, computer science or another related field required
  • 5+ years of clinical development or relevant drug development experience
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
  • Laboratory background and/or working knowledge of commonly tested biomarkers across a variety of different therapeutic areas including infectious disease and oncology setting, with latest and advanced analytics tool and assay experience preferred
  • Previous LMS (Laboratory Information Management System) experience and working knowledge of the clinical drug development process.
  • Prior experience with data transfers or management for diagnostic
  • Thorough command of FDA and ICH GCP regulations and industry standards applicable to drug development systems
  • Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy.
  • Vendor management and oversight experience
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Creative, capable problem-solver
  • Experience in regulatory GCP inspections/audits

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including:
    • Vacation, sick time and holidays
    • Volunteer time to participate within your community
    • Discretionary winter shut down
    • Paid sabbatical after 5 years; every 3 years thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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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