(Contract) Sr. Clinical Trial Manager, Clinical Operations at Moderna Therapeutics in Cambridge, Massachusetts

Job Description:

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 may report to the Director, Clinical Operations.This role may work collaboratively on one trial or across several trials to support clinical operations activities.

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 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

Here'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 preferred




• 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

About Moderna:

In 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six 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 person's 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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