Associate Director – Data Management

This is a fully remote position, open to applicants in California.

📋 Description

• Assist the Data Management (DM) department and all clinical development initiatives.

• Accountable for Electronic Data Capture (EDC) vendor oversight, managing project timelines, setting up clinical databases through to closeout, creating data management documentation, reporting on data metrics, and performing data cleaning tasks.

• Serve as the data management lead for one or more clinical studies, overseeing all data management and backend activities from database initiation through to database locking.

• Build and maintain partnerships with DM vendors and other external collaborators.

• Ensure that clinical databases and external data files are developed in a standardized, accurate, complete, and consistent manner to generate datasets suitable for analysis and regulatory submission.

• Supervise data management vendors concerning key performance indicators, metrics, program-level deliverables, and timelines.

• Review and provide constructive feedback to the clinical team on study documentation, including clinical monitoring plans, statistical analysis plans, and vendor specifications.

• Examine protocols for all data management activities to confirm proper data capture via CRF design and data requirements.

• Coordinate and engage in the review of clinical data, tables/listings/figures (TLF) analyses, and patient profiles to ensure data consistency and accuracy.

• Guarantee that all clinical trials maintain complete and accurate data along with supporting documentation for regulatory submission and data analysis, including raw datasets and annotated CRFs.

• Ensure that data management project documentation is prepared in an audit-ready format.

• Oversee the creation, validation, and maintenance of clinical trial databases in compliance with ICH/GCP guidelines and current regulatory demands.

• Manage the generation of essential documents such as data validation specifications, manual data review guidelines, data management plans, data cut plans, CRF completion guidelines, data access plans, and data transfer agreements.

• Collaborate closely with statistics and programming teams to ensure high-quality data output, which includes data cleaning/validation, SAS listings review, and TLF dry runs.

• Develop, monitor, analyze, and report on internal data management performance metrics.

• Lead initiatives for computer system development, including database integration, data sharing, access, and storage.

• Assist in setting up other systems, including the safety database and IRT.

• Contribute to budget/resource planning, re-forecasting, and program milestone tracking.

• Provide leadership, training, and support for data managers.

• Communicate and escalate project issues regarding processes, timelines, resources, performance, etc., and establish appropriate action plans with senior management.

• Aid in the preparation and support of clinical documentation for IND and NDA submissions as necessary.

• Help guide the activities of the data management team to fulfill project deliverables on schedule and in alignment with quality standards and study requirements from initiation through to archival.

• Assist in the creation of SOPs and specific quality processes and procedures for data management.

• Ensure that data management activities are performed in accordance with GCP, internal SOPs, and all regulatory requirements.

• Assist with departmental performance evaluations, goal setting, career development, and professional growth.

• Ensure that all study-specific training is current and documented for the department.

⛳️ Requirements

• A Bachelor’s Degree is required.

• At least 10 years of clinical data management experience in the biotechnology or pharmaceutical industry is required.

• Advanced understanding of data management processes and systems.

• Proficiency in setting up Clinical Databases in Medidata Rave.

• Comprehensive grasp of clinical drug development processes.

• Must be self-driven, well-organized, detail-oriented, and possess excellent written and verbal communication skills.

• Demonstrate a willingness and ability to work hands-on with a sense of urgency in a fast-paced, entrepreneurial environment.

• Must be highly resourceful and adaptable to effectively manage multiple competing demands and shifting priorities.

• Exceptional organizational skills with the capability to manage staff, projects, resources, timelines, and budgets.

• Travel requirements entail domestic and/or international travel of up to 20%.

🏝️ Benefits

• Employer-sponsored insurance plans, including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.