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 may work collaboratively on one trial or across several trials to support clinical operations activities.

Heres What Youll 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

Heres What Youll Bring to the Table:

• At least 5 five years of trial coordination experience in a clinical research and industry environment

• Advanced degree preferred or Bachelors 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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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