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:
Here's What You'll Bring to the Table:
- Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
- Lead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as required
- Perform and document study level Sponsor Oversight of outsourced clinical activities
- Communicate study-status, cost, and issues to ensure timely decision-making by senior management
- Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
- Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies
- Draft and/or oversee the drafting of site materials including training, manuals and support documentation
- Review clinical data to ensure timely entry and readiness for data review meetings
- Perform periodic review of clinical data, quality metrics and study deviations
- Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Review 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 appropriate
- Review clinical monitoring reports to ensure timely completion and identification of issues
- Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
- Complete and maintain internal clinical trial metrics, dashboards and other internal updates
- Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials
- Participate in testing of clinical trial systems/databases (i.e. UAT)
- Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
- May 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 Moderna
- Strive for continuous improvement and more efficient ways of working in clinical development
- Act as a role model for Moderna's values
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- 5-7 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management preferred
- Experience 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 preferred
- Relevant experience in global setting, across more than one phase of development, and across entire lifecycle of a study
- Solid understanding of drug development
- Good project management skills
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Excellent verbal and written communication skills
- Good organizational skills and attention to detail
- 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. 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 firstname.lastname@example.org. (EEO/AAP Employer)
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