The Senior Manager of Global Clinical Data Management (GCDM) is responsible for directly and independently managing internal staff and vendor relationships to ensure that budgets and timelines are developed by utilizing proactive strategies based on metrics and forecasts in order to deliver high quality data on time and within budget scope. This position is responsible for preserving data integrity and delivering accurate data for all data deliveries including, but not limited to, regulatory submissions and publications. This position reports to Director level GCDM.
- Identify and implement solutions to data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
- Provide leadership and functional partnering with internal and external project teams to provide data management status updates including cycle times and productivity metrics.
- Participate as a stakeholder in current and developing data technologies and/or systems.
- Assist in the formulation of short-term and long-term strategies to improve project data management efficiencies.
- Provide leadership in the development of standard practices and work instructions related to the general data management functions including, but not limited to, the following:
- Centralized MedDRA and WHO–DD dictionary coding and versioning
- Electronic data capture with Medidata RAVE and utilization of Medidata Suite products (ePRO, RTSM, Safety Gateway, etc.)
- Laboratory data standardization and collection
- Standard Case Report Form Completion Guidelines
- Standard Data Management Plans
- Data Import/Export Agreements and associated data specifications
- Participate in the development of standard practices and work instructions related to the specific data management functions including, but not limited to, the following:
- Standard CDASH case report form library and associated edit checks
- Standard edit specifications library
- Data Visualization tool development and data mapping; enhanced data cleaning and querying via use of data integration platforms
- Provide documented processes and oversee the data submission process within the GCDM department to provide submission-ready datasets and associated documentation for specific studies.
- Ensure all studies are prepared for audit inspections including documentation for database builds, data review, and data extract for all points of data and associated data flow diagrams.
- Develop request for proposals (RFPs) for external GCDM vendor contracts.
- Manage GCDM personnel, priorities, and workload on the preparation, validation, processing, reviewing, querying, dictionary coding, and maintenance of clinical data on individual clinical trials and in preparation for regulatory submissions and publications.
- Supervise, mentor and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of competency standards.
- Experience in clinical data management for 10+years. Experience in managing reports for 5+ years.
- Experience in vendor management of outsourced studies.
- Possess management experience; training and development of personnel; and preparation and conducting performance reviews.
- Possess a thorough knowledge of medical terminology; and the clinical data management and the clinical trial process.
- Proficient on regulatory requirements for data management and the regulatory submission process.
- Experience in developing SOPs.
- Proficient on the design and validation of data collection instruments; the data collection and data review process; and data standardization.
- Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding required.
- Medidata Rave experience required.
- Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
- Proficient on evaluating, testing, and managing new data standards, technologies, and systems.
- Proficient on developing request for proposals for external vendor contracts.
- Experience in solving complex and increasingly difficult problems, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data.
- Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company.
- Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
- Able to effectively coordinate personnel, vendors, teams, and projects.
- Requires a Bachelor’s degree in a scientific discipline or equivalent. A Master’s degree in a related science field is preferred.