Associate Director, Data Management

Associate Director, Data Management

The Associate Director, Data Management (AD, DM) is responsible for all aspects of the DM process from project concept, planning, development of project documentation, system set-up, UAT through database lock, and the clinical trial report. This person is a department-level contributor and may have oversight of DM staff. The core duties and responsibilities of the AD, DM are delineated below.

• Participates in the development, review, and implementation of departmental SOPs, templates, etc.
• Contributes to technical infrastructure of DM
• Responsible for timelines and quality of deliverables
• Provides feedback and task assignment to meet department and company objectives
• May have oversight of internal DM and/or contract DM staff
• Directs the activities of direct reports
• Recruit, manage, and train DM staff
• Supports budget and resource planning across assigned projects and/or projects assigned to direct reports
• Participates in CRO/vendor selection process for outsourced activities
• Participate in department and cross-functional initiatives Interacts with ClinDev, ClinOps, Biometrics, Medical Safety and Regulatory Affairs, etc. to build effective working relations internally and externally to achieve business goals
• Interact with senior management to report on project or program milestones

DM / Study Tasks:

• Represents DM in study team meetings
• Manages DM timelines to coordinate and synchronize deliverables with the overall study timelines
• Generates and/or reviews/approves study documents (e.g., study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions)
• Oversight of DM CRO/service providers (e.g. reviewing vendor SOPs, invoices)
• Monitors the progress of all DM activities for the project(s) to ensure project timelines are met
• Executes and/or distributes DM metrics, listings, and reports, as required
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
• Proactively identifies potential systemic and study issues/risks and recommends/implements solutions
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports

• Demonstrated leadership quality and superior organizational and interpersonal skills
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
• In-depth knowledge of clinical DM principles, clinical trials process and regulatory requirements (CDISC, SDTM, CDASH)
• Working knowledge of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint) and knowledge of industry standards (CDISC, SDTM, CDASH)
• Experience with web-based Electronic Data Capture (EDC), clinical Data Management systems and industry thesauri, such as MedDRA and WHO Drug.
• Proven ability to work both independently and in a team setting

• Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field
• 12 years of related DM experience in the pharmaceutical or biotechnology industry
• 3 years of managerial experience desired
• CRO management experience
• Prior oncology/hematology experience highly desirable