ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Serve as the primary internal and Sponsor contact for Data Management questions, issues or concerns including, but not limited to:
- Data delivery
- Data reconciliation
- Data Management activity timelines
- Define the Data Management Plan (DMP)
- Collaborate with Sponsors to define study requirements
- Determine standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient
- Collaborate with internal teams on study setup requirements such as demographic collection and visit schedule requirements
- Communicate contents and commitments in the DMP to the internal CDM teams
- Complete data management related pages in EXPERT (Cardiac or Pulmonary only.)
3. Lead the development, review, and finalization of Data Transfer Specification (DTS) or Load Specifications (LS) and/or Edit Check Configuration documents (EC).Provide or customize ERT standard file specifications, review and/or consult with Sponsor on Sponsor-defined specifications and coordinate finalization and approval of file specifications between Sponsors and System Analysts.
- Maintain approved file specifications (DTS or LS).
- Perform any required validation of file formats or data content.
- Submit programming requests for data file creation or edit check creation.
- Ensure updates needed to the Tasklist or DMActiveWorklist for any Programming Work Requests (eWorkRequest or PRF) are entered and work is completed.
- Ensure high customer satisfaction by delivering on promises, meeting timelines and providing excellent customer service at all times.
- Identify out of scope requests and elevate these requests to the Project Manager so that they can be properly billed through the Change Order process.
- Ensure Data Management files are up-to-date and comprehensive including, but not limited to, Data management Plans, Data Transfer Agreements, Load Specifications
- Conduct routine status meetings with Sponsor/CRO and internal teams. Provide agenda and meeting minutes to all attendees.
OTHER DUTIES AND RESPONSIBILITIES:
- Assist in the preparation of monthly reporting by providing metrics as required.
- Communicate project status clearly with Sponsors and Project Management.
- Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation.
- Lead in CAPA issues related to study-specific data management activities.
- Assist with query escalation/data cleaning.
- Assist System Analyst with performing a transfer of study data if required.