Services Summary:
The Clinical Data and Systems Manager Lead will execute and provide input on all aspects of clinical data and systems management, including CRO interface and oversight. The focus of this role will be to provide Clinical Data Management and Clinical Data Systems Management that includes management oversight of CDM deliverables from CROs and vendors, eCRF development, EDC database development, and User Acceptance Testing (UAT) of the EDC database, as well as point of contact and management of the patient facing mobile application. Consultant will provide expertise on data and systems integrations including but not limited to Medidata RAVE and patient facing applications, and will work to build internal and external team relationships.
Project Scope:
Activities for our single phase 1/2 study starting in 2020:
| Item | Description | Assumptions* |
| CRO/Vendor Oversight | Oversee/manage all data and systems deliverables from the CRO and vendors- Review and provide feedback on eCRF creation, EDC database creation and collection, Clinical Data Management documentation, medical dictionary coding guidelines, system integrations
- Drive the user requirements, integration, testing and QC of the patient-facing mobile application
- Attend/schedule CRO and vendor meetings, assessing status and adherence to set timelines and deliverables, ensuring risk mitigation strategies and resolutions are in place
- Provide data and technical expertise on data and systems integrations and collections
| - eCRF review feedback – 10 hours
- EDC database review and UAT – 20 hours
- Mobile application management – 40
- CDM documents & coding guidelines review and approval – 12 hours
- Meeting attendance – 10 hours
|
| Internal Teams | Oversee/manage sponsor data and systems deliverables- Ensure internal teams review and approve eCRFs, EDC database, Clinical Data Management documentation, medical dictionary coding guidelines, and system integrations as needed
- Ensure internals teams are provided user training on data systems
- Attend/schedule internal team meetings, reviewing status and adherence to set timelines and deliverables, and provide risk mitigation and resolution
- Work closely with internal teams to provide data and technical expertise on data and systems integrations and collections
- Manage SOWs, budgets, vendor payments, etc. as needed
- Provide risk mitigation feedback and resolutions as necessary
- Add-hoc activities as requested, such as SOP reviews, etc.
| - Meeting attendance – 10 hours
- Team management with documentation and deliverables – 10 hours
- Team training on data systems – 8 hours
|
*example month hours distribution
Time and Timelines:
Clinical Data and Systems Management activities are expected to continue for 6 months at 75% time, expected to be approximately 720 hours, although it is expected that actual time spent could vary from week to week.
