Senior Clinical Data Manager (RAVE)

RESPONSIBILITIES

The tasks of the Lead Data Manager include but are not limited to:

* Provide leadership and guidance to the data management team
* Create, track, and manage data management timelines, proposals, and budgets.
* Provide support and act as the data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
* Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members
* Develop presentations and present at Investigator meetings
* Train, track, and manage users (Sponsors, Sites, Investigators and other study personnel) on the CDMS
* Manage delivery of projects through full data management process life-cycle, including but not limited to:

* CRF/eCRF design from protocol
* Creation of CRF/eCRF Completion Guidelines
* Database design, set-up, acceptance testing in the CDMS
* Creation of the study Data Management Plan and Edit Check Specifications
* Edit check programming and validation in the CDMS
* Perform study change control as needed
* Manage and oversee both site and internal data entry and query resolution
* Perform data reviews
* Generate requested data management reports
* Perform query generation/tracking and oversee query resolution
* Perform and oversee vendor data imports and transfers
* Perform and oversee MedDRA and WHODrug coding
* Perform database lock activities

* Creation, completion, organization, and tracking of all data management documentation
* Determine project and department resource needs and data management responsibilities
* Consult with supervisors for process issues and communicate ideas for process improvement
* Assist in developing and implementing new technology
* Develop, edit, and review Standard Operating Procedures and Work Instructions as needed
* Oversee, track, and document both internal training (e.g. Standard Operating Procedures/Work Instructions, study-specific training) and external training (e.g. site CRF and EDC training)
* Follow and ensure compliance with current Good Clinical Practices (cGCPs)
* Adhere to corporate policies and procedures
* Perform other duties as required or assigned
To find out more about Real please visit www.realstaffing.com