Sr. Clinical Trial Manager, Clinical Operations, Oncology

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

Heres What YoullDo:

• 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 Modernas values

Heres What Youll Need (BasicQualifications)

• 5-7 years of experience in a clinical research and industry environment including a minimum of 2 years of independent trial management preferred

• Bachelors degree required; Advanced degree preferred

• Robust oncology experience required. Desirable: late stage experience immuno-oncology high complexity such as CAR-T.

• 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

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness mindfulness and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since 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 people are 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 to learn more about our current opportunities.

Our Working Model

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.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.