GSK
biopharma
ClinicalDataManager
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“Clinical Data Manager at GSK. Skills: Clinical Data Management, EDC Systems, GCP, Regulatory Compliance. Lead end-to-end DS&M study-related activities. Ensure quality delivery aligned to study timelines”
Industry & Context.
analytical, organizational, and problem-solving skills; Resolving operational challenges effectively
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, Computer Science, Statistics, Health Informatics, or a related field, 8+ years of experience in clinical data management or clinical trials within pharmaceutical, biotech, CRO, or academic research settings, Practical experience with electronic data capture (EDC) systems and database build activities, Demonstrated knowledge of Good Clinical Practice (GCP) and regulatory expectations for clinical data management, Experience working with external vendors, Functional Service Providers (FSPs), or outsourced clinical data services, oral and written communication skills in English, ability to collaborate effectively with global cross-functional teams, analytical, organizational, and problem-solving skills, Ability to manage multiple priorities in a fast-paced and collaborative environment
Nice to Have
Experience with EDC platforms such as Rave, InForm, Veeva, or similar systems, Familiarity with clinical data standards such as CDISC, experience preparing data for regulatory submissions, Experience leading Data Management activities for Phase II or Phase III clinical studies
What You'll Do.
Lead end-to-end DS&M study-related activities
Ensure quality delivery aligned to study timelines
Lead the creation and execution of Data Management Plans
Configure and review electronic Case Report Forms (eCRFs)
Manage interim and final cleaned database locks
Lead sponsor oversight activities for outsourced studies
Provide operational data management input into study protocols
Provide study status updates
Create and manage study-level timelines for Data Management deliverables
Promote implementation of clinical data standards
Act as the primary escalation point for Data Management study issues
Ensure all Data Management deliverables comply with GSK SOPs
Develop and maintain collaborative relationships with cross-functional teams
Mentor junior members of the DS&M team
vendor quality assessments
Support systems implementation
and training initiatives
How You'll Work.
Team & Collaboration
Collaborate effectively with global cross-functional teams; Partner closely with clinical operations, biostatistics, programming, medical writing, and external vendors; Develop and maintain collaborative relationships with cross-functional teams, global stakeholders, and external vendors; Share best practices across studies and teams
Communication Scope
oral and written communication skills in English
Process & Methodology
Manage multiple priorities, Manage study-level timelines, Ensure adherence to project milestones
Full Job Description
Are you ready to lead high-impact clinical data management activities that help drive the development of innovative medicines and improve patient outcomes? As a focused biopharma company, we discover, develop and deliver medicines and vaccines to create value for patients and shareholders. We are on track to make a positive impact on the health of 2.5 billion people by the end of the decade. In R&D, we combine the science of the immune system with advanced technologies to develop new medicines and vaccines that can help transform people’s lives. We focus on four areas – respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – where we have the strongest expertise and significant patient need remains. By developing differentiated medicines and vaccines across these areas, we can deliver patient benefit at scale and generate value for people, health systems, shareholders and society. Find out more: [Our approach to R&D](https://www.gsk.com/en-gb/innovation/) **Job Purpose** GSK is looking to hire a Clinical Data Manager to join our Data Sciences & Management (DS&M) Team. This is a hybrid role based out of Mississauga, requiring 2–3 business days per week in the office, and reports directly to the Director of Data Management. As a Clinical Data Manager, you will be responsible for leading end-to-end clinical data management activities for one or more clinical studies, ensuring high-quality data delivery, regulatory compliance, and operational excellence. You will partner closely with clinical operations, biostatistics, programming, medical writing, and external vendors to support timely study execution and database delivery. Your ability to manage multiple priorities, communicate effectively, and collaborate across global teams will be critical to success. You will also support process improvements, vendor oversight, and mentoring initiatives while contributing to GSK’s mission to help patients do more, feel better, and live longer. *****INT
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