Provides data management support, oversight, and/or accountability for one or more clinical trials.
1. Lead collaboration with trial customers and internal/external partners to establish, align, and confirm data management expectations.
2. Create, plan, and track content, format, quality, and timing of data management deliverables such as CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan, and archival.
3. Gather content and integration requirements for eCRF and other data collection tools in collaboration with trial customers and functional partners.
4. Establish conventions and quality expectations for clinical data.
5. Define expectations for dataset content and structure.
6. Set timelines and follow-up to ensure timely delivery of all Data Management milestones.
7. Perform trial-level oversight controls as described in the oversight plan, QC process, and work instructions with minimal DML direction.
8. Create clinical data management documents, including submission packages, ensuring quality, scientific content, organization, clarity, accuracy, format, and consistency, while complying with regulatory guidelines and documentation standards.
9. Ensure real-time inspection readiness of all Data Management deliverables; participate in regulatory agency audits as necessary.
10. Plan, create, and track content, format, quality, and timing of data management deliverables, including CRF, review plans, QC plans, oversight plans, database release plans, final datasets, submission plans, and archival.
11. Ensure timely delivery of all deliverables.
12. Participate in clinical working groups to meet Data Management and Therapeutic Area trial needs and deliverables.
13. Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
14. Present and provide training at investigator and monitor meetings.
Education/Experience
* BS/BA degree or higher, preferably in Health Sciences, or equivalent professional clinical experience/exposure.
* Minimum of 4 years of Data Management experience.
* At least 3 years of lead/co-lead experience.
* Vendor Management experience.
* Experience with RAVE or similar data management systems.
This role is not eligible for UK visa sponsorship.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
#J-18808-Ljbffr