Manager, Observational and Collaboration Studies, Infectious Disease

The Role:

The Manager of Observational and Collaboration Studies leads the operational support and coordinating the cross functional team for successful study delivery on multiple studies. Strong vendor management, organizational and problem-solving skills in a fast-paced environment are critical for this role. This position will work with a variety of internal and external team members, vendors and CROs. The position may report to the Director or Associate Director of Observational and Collaboration Studies. This role will work across multiple studies to support study management operations activities. The types of studies to be managed in the Observational and Collaboration Studies team include but are not limited to Post Authorization Safety Studies (PASS), Post Market Surveillance (PMS) safety studies, Registry Studies, Epidemiological studies, Real World Effectiveness (RWE) studies, Integrated Evidence studies and collaborative studies.

Heres What Youll Do:

• Perform day to day operational project management and oversight of assigned observational or collaboration studies to ensure deliverables are met for all assigned studies. Role may include ~6-10 studies depending on study complexity.

• Form the cross functional Clinical Project Team for assigned studies in consultation with the scientific study lead.

• Lead the cross functional Clinical Project Team as well as provide backup/support as a study manager representative to other team members as needed.

• Initiate and lead the vendor outsourcing activities, if applicable, in collaboration with the study scientific lead, Outsourcing, Legal, and Purchase Requisition team members and other team members as applicable.

• Manage study vendor activity during the entire project from start up to study closure.

• Perform and document study level Sponsor Oversight of outsourced activities

• Communicate study-status, timelines, budget, and issues to key stakeholders to ensure timely decision-making by management

• Initiate and manage study-level timelines, including communication to internal and external team members on deliverables

• Create, oversee, and/or organize internal team review of study documentation and reports

• Implement and ensure management of the Trial Master File, if required

• Review and provide clinical operations input into study documents such as the protocol, regulatory documents, study reports, study plans and other documents as appropriate

• Ensure biomarker study sample chain of custody is documented and tracking receipt of samples to lab vendors for analysis to meet study deliverables, if applicable.

• Complete and maintain internal clinical trial metrics, dashboards and other internal updates including CTMS, study team lists, decision making logs, etc.

• Ensure studies are conducted in accordance with Moderna and appropriate GxP, Good Pharmacoepidemiology Practices, and/or regulatory guidelines/standards, as applicable

• Participate in testing of clinical trial systems/databases (i.e. UAT), if applicable

• Manage study contracts including review/approval and tracking of invoices, budget management, budget forecasting and accrual activities

• Participate in workstreams related to departmental and operating model related initiatives to improve processes

• Develop and maintain strong, collaborative relationships with key stakeholders within and external to Moderna

• Strive for continuous improvement and more efficient ways of working in clinical development specifically with observational and collaborations studies

Heres What Youll Bring to the Table:

• 4-5 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent study or project management at a sponsor company preferred

• Bachelors degree required; Advanced degree preferred

• Relevant experience in observational research, experience in trial management or program management across more than one phase of development, and across entire lifecycle of a study preferred

• Solid understanding of drug development

• Good project management skills

• Excellent vendor management skills including contract management skills

• Critical thinker and problem solver with good organizational skills

• Ability to work with urgency and prioritize across multiple studies

• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies

• Excellent verbal and written communication skills

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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