Overseeing the end-to-end DM study related activities
Accountable for all Data Strategy & Management (DS&M) study deliverables
Act as a member of the study team and is the single point of contact for all the DM study related activities & matters
Conduct & document DM sponsor oversight of the end-to-end FSP study related activities
Provide DM operational input into the study design, protocol, planning, and study documents
Ensure DM study deliverables are in compliance with GSK SOPs and regulatory guidelines

Requirements

Bachelor's degree from Scientific Discipline (Biomedical or Computer)
1 to 3 years' experience of data management/clinical trials experience in Pharma, CRO and/or ARO
Two or more years of experience with general data flow & database architecture concepts
Two or more years of experience with clinical drug development process and regulations including ICH-GCP, 21 CRF part 11, CDISC requirement
Two or more years of experience working with industry principles of quality, safety, risk management and compliance (ICH and GCP).

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementclinical trialsdata flowdatabase architectureclinical drug developmentICH-GCP21 CFR part 11CDISCquality managementrisk management

Soft Skills

communicationleadershiporganizational skillsteam collaborationproblem-solving