If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.
In this role, you will:
- Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical
- Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listingsIprocedures used as tools for the data review and discrepancy management activities.
- Review data acquisition conventions and data review guidelinesIdiagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion
- Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
Additional responsibilities include:
- Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications I monitoring conventions, Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, ) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Advanced planning and risk management for projects (issue escalation, resource management).
- Assist with goal creation and performance review assessment for data review project staff.
- Ensure project staff are trained and adhere to project-specific, global, standardized data management processes. Support achievement of project revenue and operating margin for data management activities to agreed target
- Identify areas for process and efficiency improvement and implement solutions on assigned projects.
- Maintain technical data management competencies via pa1ticipation in internal and external training seminars.
- Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
- Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as
- Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
- Perform other duties as assigned by management.
- Review literature and research technologies/procedures for improving global data management practices.
Lead Data Managers are the most successful at Covance with:
- 5+ years of Clinical Data Management experience and at least 1 year of leading studies in a CRO setting. Combination of CRO/Pharma is acceptable.
- Bachelor's degree; additional relevant work experience considered in lieu of degree.
- Full Experience including study start up, initiation, close out etc.
- Demonstrated skill for technical management of studies with 5+ staff.
- Experience with Database Build; eCRF creation; UAT experience.
- Demonstrated mentoring/delegation, communication and interpersonal skills.