Sr. Manager, Clinical Data Monitoring

Location
Cambridge, MA
Posted
May 01, 2022
Ref
R7766
Required Education
Bachelors Degree
Position Type
Full time

The Role:

Located in Cambridge, MA and reporting to the Director, Clinical Data Management, Central Monitoring and Oversight, the Sr. Manager, Clinical Data Monitoring will be responsible for supporting development and implementation of clinical data central monitoring functionalities, tools, and analytics in collaboration with Site Monitoring, Risk Based Monitoring and Clinical Systems to ensure proper utilization and adherence of associated standard processes across the portfolio within Moderna.

Here’s What You’ll Do:

  • Support the Central Monitoring Lead in development and implementation of risk-based monitoring solutions in collaboration with cross-functional stakeholders and counterparts including Site Monitoring, Risk Based Monitoring, Digital and Clinical Systems to be utilized across all therapeutic areas within Moderna

  • Collaborate with Risk-based Monitoring, Risk Management, Clinical Data Management, Digital and Clinical Systems, to implement and adopt central data monitoring technologies, solutions, and analytics to be utilized in support of clinical data management processes.

  • Support development, implementation and maintenance of clinical data oversight metrics including KRIs and QTLs within technologies and solutions utilizing Moderna’s standards.

  • Maintain standard libraries to support central data monitoring responsibilities and activities (including Metrics, TSDV Specifications, critical data, etc.).

  • Support the creation and definition of standard central monitoring guidance, plans and templates to support study level implementations within all Therapeutic Areas.

  • Manage and communicate to cross-functional stakeholders, counterparts regarding initiatives, priorities, and timelines with respect to provision of technology and central data monitoring solutions.

  • Represent the Moderna Central Data Monitoring function across Therapeutic Areas or programs and ensures aligned expectations between external CRO partners and central data monitoring activities including study metrics and monitoring plans.

  • Provide training and guidance to study teams on standard processes across therapeutic areas for central data monitoring oversight.

  • Perform central data monitoring oversight review utilizing different technology solutions.

Here’s What You’ll Bring to the Table:

  • Bachelor’s Degree in a relevant science-based discipline is highly preferred

  • 5+ years of data science, data analysis, or clinical data management experience in industry, with experience across indications and EDC platforms.  

  • Deep understanding of drug development and biopharmaceutical Industry required.

  • Extensive knowledge of RBQM process; including thorough command of FDA and ICH GCP guidelines to ensure the appropriate handling of clinical trial data.

  • Strong management skills, and ability to effectively lead and collaborate with various business functions.

  • Demonstrates leadership, problem solving, conflict resolution, and team building skills.

  • Demonstrates ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor.

  • Proven ability to manage multiple competing priorities

  • Strong technical skills utilizing industry data visualization and central data monitoring technology solutions i.e., CluePoints, Medidata DETECT, PerkinElmer Spotfire, Looker, Tableau etc.

  • Outstanding verbal and written communication skills, in addition to excellent organizational skills.

  • Experience in regulatory GCP inspections/audits

  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.

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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