Manager, Observational and Collaboration Studies, Infectious Disease
- Moderna, Inc.
- Cambridge, MA
- Start date
- Mar 23, 2023
- Science/R&D, Infectious Disease, Pathology
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Genetown, Best Places to Work
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.
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.#LI-TR2
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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