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Clinical Data Management Director
1 month ago
The Associate Director, Clinical Data Management provides strategic leadership and clinical data expertise to project teams in an outsourced or insourced Clinical Data Management model. This role is responsible for managing all Clinical Data Management components of projects assigned, including vendor performance for outsourced studies.
Key Responsibilities- Oversee Data Management internal team and external vendors for assigned studies and projects, ensuring quality and efficiency in deliverables.
- Direct and perform study start-up activities, including clinical protocol review, budget creation, timeline creation, risk management, and data management planning.
- Direct and perform study conduct activities, including budget management, local lab normal range collection and entry, metric development and reporting, and data handling planning.
- Direct and perform study close-out activities, including timeline creation and risk management, and leading the cross-functional study management team to successfully complete all pre and post-lock requirements.
- Collaborate with internal and external database programming team members through study start-up database creation, conduct database migrations, and close-out database lock activities.
- Collaborate with Clinical Programming on the development, quality control, and maintenance of all programmed metrics, reports, and listings.
- Responsible for ensuring data collected in the clinical database and by vendors meets the requirements of the study objectives and quality standards.
- Manage the cross-functional Arcus Clinical Data Review process, including primary ownership of overall data health of a study, DM data cleaning, metric reporting, and leading data health meetings.
- Contribute Data Management expertise to cross-functional study teams, providing study status updates, timelines, risk assessment and mitigation plans, and proactive communication.
- Provide input on study documents such as Clinical Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, and Safety Monitoring Plans.
- Collaborate with Data Management Leadership to develop, review, and revise SOPs, Work Instructions, and templates.
- Maintain all Data Management documentation with proper filing into the electronic Trial Master File, ensuring preparedness for regulatory inspections.
- Bachelor's Degree or commensurate experience with 10+ years' experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center.
- Ability to train, mentor, and oversee Data Managers and their deliverables, as well as with external partners and vendors.
- Applied knowledge of ICH, FDA, and GCP regulations and guidelines.
- Proven track record of on-time and high-quality Data Management deliverables.
- Oncology experience preferred.
- Highly organized, outcome-oriented, and self-motivated.
- Ability to adapt to change in a fast-paced work and growth environment.
- Experience with EDC systems through full development life cycle. Medidata products strongly preferred.
- Applicable knowledge of industry standards and best practices such as CDISC/CDASH.
- Knowledge of and experience with MedDRA and WHO Drug data dictionaries.
- Familiarity with collection and reconciliation of data from external data sources.
- Skill and knowledge in data review listings, metrics reporting, and standards development.
- Attention to detail and the ability to work independently and proactively.
- Excellent verbal and written communication skills, including a positive disposition with colleagues.
- Strong ability in interpersonal collaboration with colleagues.
- Successful communication skills with technical concepts to cross-functional groups for awareness and understanding, as well as reporting status updates within the Arcus Data Management, Biometrics, and Clinical Development departments.
