Clinical Trial Manager, Clinical Operations, Infectious Disease

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 maywork collaborativelyon 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

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• 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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of i