Manager, Clinical Data Scientist
On-siteChennai, Tamil Nadu, India
Job Summary
Lead clinical trial data management by coordinating CDIS deliverables, selecting data acquisition standards, and defining quality risk indicators. Provide leadership and oversight to Data Managers, ensuring adherence to regulations, GCDMPs, and ALCOA principles while driving inspection readiness. Serve as a technical resource for collecting, processing, and reporting data, partnering with Research/Business Units and external providers to meet study timelines. Establish study strategies and resource allocation with Asset Leads, maintaining high-quality Trial Master File documents. Manage on-premise work within the Clinical Development & Operations organization.
Required Qualifications
- Leadership, direction, and oversight capabilities
- Accountability for trial inspection readiness
- Selection and application of data acquisition standards
- Data Management Plan creation
- Selection of quality risk indicators
- Third party study data due diligence
- Application of CDIS best practices
- Collection, processing, consumption, and reporting of clinical trial data
- Quality and timeliness assurance of CDIS deliverables
- Collaboration with Research/Business Units, external data/service providers, and internal CDIS staff
- Proactive driving of quality and efficiency to meet study/asset timelines
- Adherence to applicable SOPs and work practices
- Assurance of adherence to regulations, standards, GCDMPs, and ALCOA principles
- High quality and contemporaneous filing of required study-specific CDIS documents in the Trial Master File (TMF)
- Establishment of strategy, timelines, and adequate resourcing for studies
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.