Job description

Reporting to the Vice President, Biometrics, the Associate Director, Clinical Data Management is responsible for leading all clinical data management activities for one or multiple projects including CRF design, database development, processing external data, medical coding, data review, SAE reconciliation, and database close/lock procedures in accordance with ICH Guidelines and company requirements. Additionally, this role is responsible for the Data Management timeline, budget, quality management, vendor relationship and the facilitation of all projects requiring the data management support.

A successful candidate will have had experience contributing strong Data Management knowledge and consultation to a clinical program team, as well as to other stakeholders within Development. This role will be the company subject matter expert (SME) to DM process and technical/systems improvement initiatives.

Responsibilities

• Demonstrate subject matter expertise in all aspects of the Data Management (DM) discipline. Ability to support multiple studies concurrently with minimal oversight by functional manager
• Advocate for the DM position within study team meetings and oversee vendor staff supporting DM work
• May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, data visualization, etc.
• May contribute subject matter expertise to support process improvement initiatives (e.g., data storage infrastructure, Master Control) and SOP authorship
• Participate in study and department-level budget review activities for all DM tasks and line items
• Coordinate with the Vendor DM, Biostatistics, and Clinical on database UAT, edit checks, CRF completion guidelines, data management plans, data review plans, change control processes, and other study-specific plans as required
• Develop, generate, and review project progress and/or metric reports, reporting summary of findings and data trends from vendor databases
• Develop a strong partnership with vendor Lead Data Managers to ensure program level deliverables are on track
• Lead the data review meetings with Medical, Clinical, Biostatistics, and Programming in support of key reporting events or database lock plans

Requirements

• BS/BA degree in a biological science, health-related, or computer science field
• 8 plus years related experience in pharmaceutical or clinical research industries, with a minimum of 7 years experience as Data Manager, with progressive levels of experience with varying study types and phases (Phase III experience would be preferred)
• Knowledge of clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP), CDISC standards, and eCTD submission requirements
• Solid cross-functional understanding of processes of data management, clinical programming, biostatistics, and clinical and the ability to support studies across multiple phases of development
• Proven competence in managing delivery of multiple projects/programs independently through full data management study life cycle
• Prior inspection and major (vendor) audit experience a plus
• Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
• Experience with EDC and ePRO systems/devices and the implementation of such systems
• Strong knowledge of medical terminology, including implementation and use of the WHO Drug and MedDRA dictionaries
• Professional communication skills, and excellent problem-solving, organizational and project management abilities
• Hybrid role out of Watertown, MA

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