Data Team Lead - homebased FSP
Data Team Lead - homebased FSP
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Provides data management support oversight and/or accountability for one or moreclinical trials.
- Take the lead with the trial customer(s) and other internal and externalpartners to establish align and confirm data management expectations
- Creating planning and tracking content format quality and timing of data management deliverables including but not limited to CRF data review plan QC plan oversight plan database release plan final datasets submission plan and archival.
- With the trial customer and other functional partners: Gathers content andintegration requirements for eCRF and other data collection tools.
- Establishesconventions and quality expectations for clinical data.
- Establishes expectations for dataset content and structure.
- Set timelines and followup to ensuredelivery of all Data Management milestones.
- Performs trial level oversight controls as appropriate as described in the oversightplan QC process and work instructions with minimal DML direction.
- Creates clinical data management documents (including submission package) ensuring appropriate quality scientific content organization clarity accuracyformat and consistency. Ensures compliance with regulatory guidelines and thedocumentation matrix.
- Ensures realtime inspection readiness of all Data Management deliverables for thetrial; Participate in Regulatory Agency and audits as necessary.
- Helps plan create and track content format quality and timing of data
- management deliverables including but not limited to Case Report Form datareview plan QC plan oversight plan database release plan final datasetssubmission plan and archival.
- Ensures deliverables are on time.
- Participates in the assigned clinical working group(s) to ensure that Data
- Management and Therapeutic Area trial needs and deliverables are met.
- Helps Identify and communicate lessons learned best practices and frequentlyasked questions at the trial level.
- Presents and trains at investigator and monitor meetings
Education/Experience
- BS/BA degree or higher preferably in Health Sciences or BS/BA degree or higher with professional clinical experience/exposure.
- 4 years Data management experience.
- 3 years lead/colead experience
- Vendor Management experience
- RAVE experience
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
Employment Type
Full-Time
