Clinical Trial Manager, Clinical Operations

**The Role**:
The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring 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 and is accountable to the Clinical Operations Lead for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

**Here’s What You’ll Do**:
Day to day management of assigned clinical trial(s) to ensure deliverables are met in all phases of trial

Communication to internal team members on deliverables and ensuring timelines are met

Manage trial feasibility process

Work closely with study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studies

Drafting site materials including training, manuals and support documentation

Monitoring of clinical data to ensure timely entry and readiness for data review meetings

Periodic review of clinical data

Review of 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

Maintain trial metrics

Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials

Support testing clinical trial systems/databases (i.e. UAT)

May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacity

Develop and maintain strong, collaborative relationships with key stakeholders within Moderna

**Here’s What You’ll Bring to the Table**:
At least 5 five years of trial coordination experience in a clinical research and industry environment

Relevant experience in global setting

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

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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.

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