Moderna
Sr. Manager, Clinical Data Management
Cambridge, Massachusetts, USA · Senior
Sponsorship not specified$131k-$209kDetected 15 days ago
SQLVendor ManagementResearchGxPBiostatistics
About the role
- Manager, Clinical Data Management for its Cambridge, Massachusetts location.
- Responsible for vendor oversight activities across global development programs.
- Provide input to functional governance with Moderna strategic suppliers.
Responsibilities
- Lead data management activities for in-house and outsourced studies.
- Represent data management function in clinical cross-functional meetings, ensuring aligned expectations between the Contract Research Organization (CRO) and Moderna for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Partner with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
- Lead and manage clinical trial data collection set-up, data review, and database lock for studies where data management activities are conducted within Moderna.
- Lead the creation and maintenance of study cross functional data review plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, Serious Adverse Events (SAE) reconciliation guidelines, and database lock plans.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Plan and manage external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Requirements
- Requires a Bachelor's degree, or foreign equivalent, in Biotechnology, Biology, Biological Sciences, or related field and 8 years of progressive, post-baccalaureate experience as a Sr.
- 7 years of experience must include:
- Ensure established milestones and deliverables are met with the highest degree of quality.
- Lead data review, including query management, and activities required for interim and final database locks.
Skills
- Champion and adopt technology improvements and tools for use in clinical data management processes.
Compensation
- The salary range for this role is $130,800 to $209,400.
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This listing is sourced directly from Moderna's careers page and normalized into a canonical job model.