Sr. Manager, Clinical Risk Management Strategy

The Role:
The Senior Manager, Clinical Risk Management Strategy will be responsible for driving and supporting clinical trial teams with the end-to-end Moderna Clinical Risk Management strategy framework. This role will partner with the Clinical Trial Teams, Clinical Compliance and Inspection Readiness, R&D Quality, Central Monitoring and Oversight, and Monitoring Strategy and Execution teams. This is a highly collaborative and dynamic role within a fast paced and results oriented environment. Applicants should be outstanding team members with the ability to effectively communicate and collaborate cross-functionally.

Heres What Youll Do:

• Support clinical trial teams in the (a) identification of critical data and processes, (b) evaluation of likelihood, detectability, and impact of risks, (c) acceptability of risks and required risk reductions, (d) documentation and reporting of risks, and (e) review of effectiveness of risk control measures

• Responsible for working with clinical trial teams to perform the initial cross-functional risk assessment and ongoing cross-functional risk assessment as part of their management of the overall clinical risk assessment, control, and review

• Support clinical trial teams in understanding and performing adequate sponsor oversight of CRO partners and the risk management process, when applicable

• Facilitate clinical risk reviews with cross-functional team members

• Develop and maintain study level Clinical Risk Management plans

• Provide study and/or program level input to the Central Monitoring Oversight and Monitoring Strategy and Execution teams on quality tolerance limits (QTLs) and key risk indicators (KRIs), centralized monitoring approach, on-site vs. remote monitoring, and SDV and SDR requirements

• Partner with the clinical trial teams to ensure appropriate actions are taken to investigate, resolve, and document new risks identified via data review, including adequate documentation of resolution

• Contribute to and support maintenance of Modernas risk, metrics, QTL, and KRI libraries

Heres What Youll Bring to the Table:

• Bachelors degree required; advanced degree preferred; or relevant experience

• Minimum of 5+ years of experience in clinical research and development, and at least 2+ years in roles focused on clinical risk management or RBQM

• Knowledge and understanding of RBQM

• Knowledge and understanding of ICH GCP and other applicable guidelines

• Experience with compliance/risk management best practices

• Ability to collaborate and handle a high volume of complex tasks within a given timeframe

• Excellent written and verbal communication skills

• Flexibility to adapt to the dynamic needs of a growing company

• Understanding of drug development across all phases and multiple therapeutic areas

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 year-end shutdown
  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 persons 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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