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Manager, Observational and Collaboration Studies

3 months ago

Cambridge, United States Moderna Full time

**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.

**Here’s What You’ll 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

**Here’s What You’ll 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

Bachelor’s 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