The Role:The Manager of Observational and Collaboration Studies leads the operational support and coordinating the cross functional team for successful study delivery on multiple studies. Strong vendor management, organizational and problem-solving skills in a fast-paced environment are critical for this role.This position will work with a variety of internal and external team members,vendors and CROs. The position may report to the Director or Associate Director of Observational and Collaboration Studies. This role will work across multiple studies to support study management operations activities. The types of studies to be managed in the Observational and Collaboration Studies team include but are not limited to Post Authorization Safety Studies (PASS), Post Market Surveillance (PMS) safety studies, Registry Studies, Epidemiological studies, Real World Effectiveness (RWE) studies, Integrated Evidence studies and collaborative studies.Here's What You'll Do:Perform day to day operational project management and oversight of assigned observational or collaboration studies to ensure deliverables are met for all assigned studies. Role may include ~6-10 studies depending on study complexity.Form the cross functional Clinical Project Team for assigned studies in consultation with the scientific study lead.Lead the cross functional Clinical Project Team as well as provide backup/support as a study manager representative to other team members as needed.Initiate and lead the vendor outsourcing activities, if applicable, in collaboration with the study scientific lead, Outsourcing, Legal, and Purchase Requisition team members and other team members as applicable.Manage study vendor activity during the entire project from start up to study closure.Perform and document study level Sponsor Oversight of outsourced activitiesCommunicate study-status, timelines, budget, and issues to key stakeholders to ensure timely decision-making by managementInitiate and manage study-level timelines, including communication to internal and external team members on deliverablesCreate, oversee, and/or organize internal team review of study documentation and reportsImplement and ensure management of the Trial Master File, if requiredReview and provide clinical operations input into study documents such as the protocol, regulatory documents, study reports, study plans and other documents as appropriateEnsure biomarker study sample chain of custody is documented and tracking receipt of samples to lab vendors for analysis to meet study deliverables, if applicable.Complete and maintain internal clinical trial metrics, dashboards and other internal updates including CTMS, study team lists, decision making logs, etc.Ensure studies are conducted in accordance with Moderna and appropriate GxP, Good Pharmacoepidemiology Practices, and/or regulatory guidelines/standards, as applicableParticipate in testing of clinical trial systems/databases (i.e. UAT), if applicableManage study contracts including review/approval and tracking of invoices, budget management, budget forecasting and accrual activitiesParticipate in workstreams related to departmental and operating model related initiatives to improve processesDevelop and maintain strong, collaborative relationships with key stakeholders within and external to ModernaStrive for continuous improvement and more efficient ways of working in clinical development specifically with observational and collaborations studiesHere's What You'll Bring to the Table:4-5 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent study or project management at a sponsor company preferredBachelor's degree required; Advanced degree preferredRelevant experience in observational research, experience in trial management or program management across more than one phase of development, and across entire lifecycle of a study preferredSolid understanding of drug developmentGood project management skillsExcellent vendor management skills including contract management skillsCritical thinker and problem solver with good organizational skillsAbility to work with urgency and prioritize across multiple studiesGood understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studiesExcellent verbal and written communication skillsModerna 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince 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 peopleare 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 Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.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. We're 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 contact the Accommodations team at ****** . (EEO/AAP Employer) -
