Associate Clinical Trial Manager, Clinical Operations, Infectious Disease

Moderna; United States; On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Healthcare

Well-being resources

Family planning benefits

Paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking an Associate Clinical Trial Manager to oversee comprehensive trial planning, execution, and cross-functional collaboration under the Clinical Operations Lead. You will manage study responsibilities, assist with strategy and budgets, and coordinate CROs and vendors across multiple trials.

The role requires 2+ years in trial coordination, a science background, global trial experience, and strong project management skills to ensure adherence to FDA/ICH GCP guidelines and timely

Qualifications

• 2+ years of trial coordination in clinical research/industry
• Advanced degree preferred or Bachelor's in science
• Experience in global clinical trials environment

Responsibilities

• Manage day-to-day assigned study responsibilities to ensure deliverables across trial phases
• Deputize for Clin Ops Lead as needed
• Develop and manage study documents (protocols, consent forms, CSAs) and reviews
• Assist in clinical development strategy, budgets, and timelines under Clin Ops Lead
• Oversee CRO activities and subcontracted vendors with Clin Ops Lead
• Participate in CRF review, data review, and CRF completion guidelines
• Contribute to ED C/IRT system builds and testing
• Assist in site feasibility and budgeting for clinical sites
• Coordinate IP delivery with Clinical Supply team
• Support regulatory submissions to IRB/IEC and authorities
• Ensure trial activities comply with Moderna and ICH/GCP standards

Skills

Trial coordination

Project management

Vendor management

Global trials

FDA/ICH GCP

Communication

Budget planning

Education

Advanced degree preferred

Bachelor's in science

Tools

EDC

IRT

TMF

Job description

The Role

The Associate Clinical Trial Manager is involved in overall management, planning, implementation and execution of trials with oversight from the Clinical Operations Lead.

Here's What You'll Do

• Day to day management of assigned study responsibilities as delegated by the Clin Ops Lead to ensure deliverables are met in all phases of trial. This includes but is not limited to: management of small studies at various points in the trial lifecycle, managing regions or countries within a larger clinical trial, managing vendors or activities across multiple trials.
• Deputize for Clin Ops Lead, as needed
• Contribute to development of study documents (protocol, consent forms, clinical study plans, etc.), including drafting updates and managing reviews
• Assist team with clinical development strategy, budget, and plan and manage study-level timelines with oversight from Clin Ops Lead
• Management and oversight of assigned CRO activities and/or subcontracted vendors activities, under oversight from Clin Ops Lead
• Participate in clinical review of CRFs, CRF completion guidelines, and data review
• Participate in clinical system build and test efforts (EDC, IRT, etc.)
• Assist in identification and selection of clinical sites, including feasibility process
• Assist in monitoring and managing budgets and contracts for clinical sites
• Provide input and coordinate delivery of IP to sites in collaboration with Clinical Supply team
• Collaborates and supports Clin Ops Lead and/or Program Clin Ops Lead to perform key tasks within the clinical trial process such as monitoring oversight, managing clinical trial insurance, deviation processes and clinical quality metrics.
• Support maintenance of trial metrics, including routine reporting as assigned
• May perform some Clinical Trial Associate tasks if required, including mentoring of new CTAs
• Support team with submissions to IRB/IEC and regulatory authorities
• Liaise and coordinate document upload and QC checks with TMF team
• Ensure assigned trial or part of trial is conducted in accordance with Moderna and ICH/GCP standards

Here's What You'll Bring To The Table

• At least 2 years of trial coordination experience in a clinical research and industry environment with up to 5 years 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 $89,900.00 - $143,800.00(for positions that may be performed in California, the expected salary range is $111,600.00 - $128,400.00, which reflects the range permitted under California Labor Code requirements) . 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.

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].

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 applicant’s 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.