Senior Clinical Data Manager
Remote Worker - N/A
The Senior Clinical Data Manager manages all data relating to various studies.
- Provide leadership and guidance to the data manager and data coordinator.
- 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/or 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
- Other duties as assigned
No travel required
- The position requires at least a Bachelor’s Degree in clinical, biological, or mathematical sciences with minimum of 7 years of experience in Clinical Data Management in Clinical Trials.
- At least 3 years of working experience on Medidata RAVE platform, build EDC in Medidata RAVE or equivalent EDC platform. Certified RAVE builder is a plus.
- Comprehensive experience with at least one clinical data management system (CDMS) including direct experience and/or understanding with database design, set-up and user acceptance testing; edit check development and/or programming and validation; management of data entry and queries; and study change control.
- Thorough knowledge of all data management processes from study start-up to study close-out.
- Knowledge of medical terminology, pharmacology, anatomy, and physiology.
- Previous experience and proven competence in managing delivery of projects through full data management study life-cycle (Phase I, Phase II and Phase III).
- Comprehensive understanding of clinical drug development processes.
- Excellent computer, organizational, and communication skills.
- Experience working on both paper and electronic data management studies.
- Direct experience designing and creating paper and a clear understand of electronic Case Report Forms (CRFs/eCRFs).
- Experience performing SAE Reconciliation.
- Experience with performing user acceptance testing and validation and associated documentation.
- Experience with creating and managing data management proposals and budgets.
- Good Clinical Practices training.
- Experience with the following preferred but not required:
- Medrio (CDMS)
- Adobe InDesign software
- Microsoft Access