Associate Director – Data Management

Role Overview

• Act as the data management lead for one or more clinical studies including responsibility for all data management and back-end activities from database start-up through database lock
• Establish and oversee partnerships with DM vendors and other external partners
• Ensure clinical databases and external data files are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and regulatory submission
• Oversee data management vendors with respect to key performance indicators, metrics, program level deliverables, and timelines
• Review and provide feedback to the clinical team on study documents, including clinical monitoring plans, statistical analysis plans and vendor specifications
• Review protocols for all data management activities to ensure data is properly captured via CRF design and data requirements
• Coordinate and participate in the review of clinical data, tables/listings/figures (TLF) analysis, and patient profiles for data consistency and accuracy
• Ensure that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis, including raw datasets and annotated CRFs
• Ensure data management project documentation is in an audit-ready format
• Oversee the building, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
• Oversee the generation of key documents such as data validation specifications, manual data review guidelines, data management plans, data cut plans, CRF completion guidelines, data access plan, data transfer agreements, etc.
• Work closely with statistics and programming to ensure high-quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc.
• Develop, track, analyze, and report internal data management performance metrics
• Lead computer system development initiatives including database integration, data sharing, access, and storage
• Support the setup of other systems such as the safety database and IRT
• Contribute to budget/resource planning, re-forecasting and program milestones
• Provide leadership, training, and support to data managers
• Communicate and escalate project issues involving processes, timelines, resourcing, performance, etc. and establish appropriate courses of action with senior management
• Assist in the preparation and support of clinical documentation for IND and NDA submissions as appropriate
• Assist with directing the activities of the data management team to complete project deliverables on schedule and per quality standards and requirements from study start-up through archival
• Assist with the development of SOPs and specific quality processes and procedures for data management
• Ensure data management activities are conducted in accordance with GCP, internal SOPs, and all regulatory requirements
• Assist with departmental performance evaluations, goal setting, career development, and growth
• Ensure all study specific training is kept up to date and documented for the department

Requirements

• Bachelor’s Degree required
• Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry required
• Advanced knowledge of data management processes and systems
• Advanced knowledge of setting up Clinical Databases in Medidata Rave
• Solid understanding of clinical drug development processes
• Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
• Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
• Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
• Excellent organizational skills with the ability to manage staff, projects, resources, timelines, and budgets
• Travel requirements include travel domestically and/or internationally up to 20%

Tech Stack

• Google Cloud Platform