Director, Data Management

• Oversees the data management activities for outsourced studies and manages vendors responsible for performing those activities from start-up through database lock.
• Establish Program(s) or Portfolio level strategies and services; accountable for the management of vendor partnerships to maximize effectiveness and maintain budgets.
• Provides data management expertise and capability in support of global development programs; identifies and executes industry best practices.
• Leads the creation, maintenance, and execution of Marinus study data review plans developing and executing Marinus internal data review, including resulting query management and resolution.
• Support the DM team in data management function on the study team(s) ensuring aligned expectations between the CRO/Vendor and Marinus for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Oversees data management vendor deliverables according to timelines including but not limited to edit checks (data validation plan), data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, and database lock plans.
• Performs management & oversight of all study-level data capture (e.g., EDC, IRT, ePRO, eCOA) technologies and other related vendors and/or applications.
• Partners with appropriate stakeholders from the vendor and/or cross-functional teams to ensure data quality and on time delivery; seeks creative solutions and resolves issues.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents; participates in preparing function for submission readiness.
• Responsible for the achievement of major data management deliverables and milestones in coordination with other functions.
• Develops SOPs, process maps and templates and timelines to support functions operational and oversight models.

• Minimum Bachelor's degree is required, preferably in a scientific or health related discipline. Advanced degree preferred.
• Minimum 10 years of pharmaceutical/biotech data management and drug development process experience with expertise in the data management function including management of data across drug development programs is required.
• Experience with all phases of development in one or more therapeutic areas preferred
• Experience implementing data management best practices, industry data management standards and developing an organization's data management function required.
• Demonstrated expertise providing input into clinical trial documents (statistical analysis plans, CRFs, study reports) required
• Experience managing vendor relationships and alliances including budgetary responsibility is required.
• Line management experience and managing a team of direct reports is required.
• NDA/CTD experience preferred.
• Up to 15% travel may be required based upon business needs

• For this role, the anticipated base salary range: $190,000 to $225,000, based upon the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Marinus also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
• For additional general information on company benefits, please go to:https://marinuspharma.com/about-marinus/join-our-team/

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