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!
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 a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at firstname.lastname@example.org. (EEO/AAP Employer)