The Role:The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director, Clinical Operations.This role may work collaboratively on one trial or across several trials to support clinical operations activities. This position will focus on rare disease, but in the future may work across programs and studies within Therapeutics.Here's What You'll Do:Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trialLead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as requiredPerform and document study level Sponsor Oversight of outsourced clinical activitiesCommunicate study-status, cost, and issues to ensure timely decision-making by senior managementInitiate and manage study-level timelines, including communication to internal and external team members on deliverablesWork closely with other supporting clinical operations team members, if applicable, to execute clinical studiesDraft and/or oversee the drafting of site materials including training, manuals and support documentationReview clinical data to ensure timely entry and readiness for data review meetingsPerform periodic review of clinical data, quality metrics and study deviationsManage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional teamReview and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriateReview clinical monitoring reports to ensure timely completion and identification of issuesEnsure trial samples are ready to be sent to vendors in order to meet trial deliverablesComplete and maintain internal clinical trial metrics, dashboards and other internal updatesEnsure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trialsParticipate in testing of clinical trial systems/databases (i.e. UAT)Manage invoice and budget tracking for individual studies and provide input into budget forecasting activitiesMay support additional clinical trial(s) in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.)Participate in clinical operations workstreams related to departmental and operating model related initiatives Develop and maintain strong, collaborative relationships with key stakeholders within and external to ModernaStrive for continuous improvement and more efficient ways of working in clinical developmentAct as a role model for Moderna's valuesHere's What You'll Bring to the Table:5-7 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management preferredExperience with early phase complex global trials required. Rare disease experience required. Diverse trial experience across phases and multiple therapeutic areas desirable (oncology, autoimmune/ immune mediated, cardiovascular).Bachelor's degree required; Advanced degree preferredRelevant experience in global setting, across more than one phase of development, and across entire lifecycle of a studySolid understanding of drug developmentGood project management skillsGood understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studiesExcellent verbal and written communication skillsGood organizational skills and attention to detailModerna 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.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 make a request to the Talent Acquisition Partner or contact the Accommodations team at ****** . (EEO/AAP Employer) -
