We are seeking an experienced candidate for the role of Associate Data Management Director to lead data management functions related to planning, execution, collection and cleaning of clinical data. This individual will collaborate with biostatistics, programming, clinical development, regulatory affairs and outside vendors. This position will have responsibilities in defining Sponsor processes and procedures for maintaining clinical data and the associated quality documents.
- Develop and implement strategic vision for data management (DM) group.
- Directs the management of clinical trial data and utilization of clinical data systems.
- Oversees and ensures that all DM related activities on trials are conducted to budget, timelines and are delivered with high quality, from study start up through the final clinical study reporting.
- Take a leadership role in the review and query of clinical data. This includes the critical review of data-populated LTFs as part of the database clean-up and prior to database lock.
- Review statistical analysis plans and ensure data quality for data analyses.
- Provide oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.
- Ensures DM compliance to agency regulations, guidelines and departmental SOPs, and protocols.
- Extensive experience managing varying data sources to identify, evaluate, recommend, and implement the most efficient solutions for obtaining and streamlining data workflows.
- Manages all vendor activities from qualification and process auditing to financial management, including but not limited to contract negotiations, accrual reporting, budget reconciliation and invoicing.
- Drives process improvements and is accountable for staff compliance, results and achievements.
- Manage and mentor DM team members.
- BA/BS degree in biological sciences, computer science or related field
- Minimum of 8 years of experience in design, management of clinical data and the analysis and reporting of study results in the pharmaceutical/ biotechnology/ CRO setting.
- Extensive knowledge of GCP, CDASH/CDISC and regulatory requirements regarding clinical data management documentation and software
- Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug)
- Strong verbal and written communication skills as well as interpersonal and organizational skills
- Attention to detail, ability to prioritize and handle multiple projects.
- Proficiency in MS Office applications
- Self-starter, able to communicate well within a team environment. Candidate will be proactive in managing and completing tasks in a timely fashion
- **DataFax experience is preferred.