Clinical Trial Manager, Clinical Operations, Infectious Disease

Moderna Therapeutics; Cambridge (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Competitive healthcare

Paid time off

Global benefits

Job summary

Moderna Therapeutics in Cambridge, MA seeks a Clinical Trial Manager to oversee assigned trials, ensuring quality, compliance and timely delivery. You will manage CROs/vendors, collaborate with Clinical Operations, draft site materials, monitor data, and maintain trial metrics across global regions.

The role requires 5+ years of trial coordination experience, strong FDA/ICH GCP knowledge, and exceptional communication and project management skills.

Qualifications

• At least 5 years of trial coordination experience in a clinical research/industry setting.
• Advanced degree preferred or Bachelor’s in a science-based subject.
• Relevant experience in global settings.
• Solid understanding of drug development.
• Good project management skills.
• Good understanding of FDA and ICH GCP guidelines for appropriate conduct of clinical studies.
• Excellent verbal and written communication skills.
• Good organizational skills and attention to detail.

Responsibilities

• 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 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.

Skills

Trial coordination

Vendor management

Clinical operations

GCP knowledge

Communication skills

Education

Advanced degree preferred

Bachelor’s in science

Job description

The Role:

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
• Advanced degree preferred or Bachelor’s in a science-based subject
• 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

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

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 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 a place where everyone can grow.

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re 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 [e-mail].

Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.