Director Clinical Data Management (100% With Location Us)

Noema Pharma is a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks.
Tasks

• Leads data management activities for outsourced studies and manages vendors responsible for performing those activities from start-up through database lock.
• Responsible for the achievement of major data management deliverables and milestones in coordination with other functions.
• 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.
• Performs management & oversight of all study-level data capture (e.g., EDC, IRT, ePRO, eCOA) technologies and other related vendors and/or applications.
• May prepare metrics to support the function’s KPIs.
• Provides data management expertise and capability in support of global development programs; identifies and executes industry best practices.
• Represents data management function on the study team(s) ensuring aligned expectations between the CRO and Noema for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Performs other duties as assigned.
• Domestic/international travel (5-15%) may be required.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents; participates in preparing function for submission readiness.
• 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.
• Establish Program(s) or Portfolio level strategies and services; accountable for the management of vendor partnerships to maximize effectiveness and maintain budgets.
• Develops SOPs, process maps and templates and timelines to support functions operational and oversight models.
• Leads the creation, maintenance and execution of Noema study data review plans developing and executing Noema’s internal data review, including resulting query management and resolution.

Requirements

• Ability to travel domestically and internationally.
• 7+ years data management and drug development process with expertise in the data management function including project management and management of data across drug development programs.
• Experience implementing data management best practices, industry data management standards and developing an organization’s data management function.
• Fluent in English; facility with multiple languages a plus.
• Demonstrated expertise providing input into clinical trial documents (protocols, statistical analysis plans, CRFs, study reports).
• NDA/CTD Experience preferred.
• At least 2 years’ experience managing vendor relationships and alliances.
• Experience with all phases of development in one or more therapeutic areas preferred.
• Bachelor’s Degree or international equivalent preferred.
• Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Minimum 2 years of line management experience or equivalent.