Sr. Clinical Trial Manager, Clinical Operations, Infectious Disease

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its presence in Tokyo, a city known for its blend of tradition and innovation. Our new commercial office here will focus on bringing our advanced mRNA products to the Japanese market. Nestled in the heart of Tokyo's vibrant landscape, we're looking to integrate into the local biotech scene while contributing our global expertise. We welcome professionals who are passionate about making a difference in healthcare to join our team. Here, you'll be part of a community dedicated to simple yet profound goals: enhancing health outcomes and providing cutting-edge treatments in Japan. Join us in Tokyo where your efforts will help shape the future of medicine in an environment that values both tradition and innovation.

An exciting opportunity has arisen for a Sr. Clinical Trial Manager (Sr. CTM) at Moderna. In this role, you will provide critical oversight to assigned clinical trials, which may be complex or high-priority, ensuring that all deliverables are met with the highest quality, in compliance, and on time. Your strong vendor management skills will be key, as you work with internal team members, sites, external vendors, and CROs. Reporting potentially to the Director of Clinical Operations, this position might collaborate across one or several trials to support clinical operations activities effectively.

Here's What You’ll Do:

Your key responsibilities will be:

• Managing and overseeing the day-to-day operations of assigned clinical trials, ensuring all phases of the trial meet deliverables.

• Leading the Clinical Trial Team and supporting other development teams as a Clinical Operations representative as required.

• Performing and documenting study-level Sponsor Oversight of outsourced clinical activities.

• Communicating study status, costs, and issues to facilitate timely decision-making by senior management.

• Initiating and managing study-level timelines, including communicating deliverables to both internal and external team members.

• Working closely with supporting clinical operations team members to execute clinical studies effectively.

Your responsibilities will also include:

• Drafting and overseeing the drafting of site materials, reviewing clinical data, managing trial feasibility, and overseeing site assessments in collaboration with the CRO and cross-functional teams.

• Participating in the testing of clinical trial systems/databases and managing invoice and budget tracking for individual studies.

• Ensuring the trial conforms to Moderna and ICH/GCP standards across multiple regions in global trials.

• Developing and maintaining strong relationships with key stakeholders within and external to Moderna, acting as a role model for Moderna’s values.

The key Moderna Mindsets you’ll need to succeed in the role:

• Act with dynamic range: This role requires driving strategy and execution simultaneously, making real-time decisions that affect the outcome of our clinical trials.

• Push past possible: Embracing challenges and pushing the boundaries of what's possible to advance Moderna's mission in transforming medicine through mRNA technology.

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

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.
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

-