Director, Clinical Data Management

Role Summary

Director, Clinical Data Management. Based in San Diego, CA with a hybrid onsite requirement (minimum 2 days/week). Responsible for the oversight of all data management operational activities to ensure high-quality data and on-time delivery of CDM work from study start-up through close-out and regulatory submission.

Responsibilities

• Provides operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards.
• Oversees vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all CDM services from study start-up through study close-out and final reporting.
• Responsible for building effective Data Management vendor relationships for all assigned studies, including involvement in RFP development, contract negotiation and selection of DM and/or technology.
• Creates and/or reviews study-specific Data Management and database documentation which may include data management plans, CRF completion guidelines, coding guidelines, annotated CRFs, and edit check specifications.
• Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets conducive to analysis and regulatory submission by working with lead CRO data manager or equivalent.
• Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy.
• Ensures clinical data within the clinical database is of high quality and suitable for lock as appropriate for clinical review and statistical analysis.
• Ensures that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis, including raw datasets and bookmarking annotated CRFs.
• Maintains study-specific files to enable reconstruction and evaluation of data management conduct in a clinical trial.
• Manages data management timelines; coordinates and synchronizes deliverables and milestones with overall timelines.
• Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications.
• Provides training on CRF completion guidelines and EDC system at Investigators' meetings and to internal and external project members as needed.
• Adheres to all department and company-wide policies regarding conduct, performance and procedures.
• Provides oversight and direction to direct and indirect reports in accordance with the organization’s policies and procedures, including recruiting, training, communicating expectations, appraising and managing performance, delivering feedback and coaching, and providing career development opportunities.
• Performs other duties as required.

Qualifications

• Required: BS in Life Sciences, Computer Sciences or Mathematics; minimum 12 years of related experience; at least 5 years of data management experience in the pharmaceutical/biotech industry; at least 5 years of people management experience; prior clinical trial responsibility for the entire data management life cycle.
• Required: Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Required: Strong technical skills including CDISC, STDM, MeDRA.
• Required: Understanding of data management technology, software languages and computer systems.
• Required: Sound knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Required: Competency in multiple computer-based tools, including Word, PowerPoint, Excel, etc.
• Required: Ability to work in and effectively contribute to cross-functional teams in person, by telephone, and by email.
• Required: Excellent verbal and written interpersonal skills.
• Required: Ability to create strong, collaborative working relationships and encourage creative solutions by effectively working through conflicts.
• Required: Ability to demonstrate competencies applicable for the job based on Leadership Competency Model.
• Required: Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.
• Required: Ensures employee performance meets the organization's expectations for conduct, productivity, quality, continuous improvement, and goal achievement.

Education

• Bachelor's degree in Life Sciences, Computer Sciences or Mathematics (or equivalent) as a minimum educational requirement.

Additional Requirements

• Occasional travel may be required, including travel between Pasadena and San Diego offices.