GSK
biopharma
ClinicalDataLead
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Data Lead at GSK. Skills: Clinical Data Management, Data Management strategy, Regulatory requirements. Lead end-to-end clinical data management activities. Ensure high-quality data delivery”
What You'll Achieve.
High-quality data delivery; Regulatory compliance; Operational excellence; Timely study execution; Database delivery; Help patients do more, feel better, and live longer
Industry & Context.
Problem-solving mindset
What They're Looking For.
Must Have
Bachelor's degree in a scientific, health-related, or business discipline, Experience with Clinical Data Management processes, standards, and clinical systems, Proficiency in Microsoft Excel and validation methodologies, Understanding of data flow processes and database architecture concepts, Good understanding of regulatory requirements and industry standards, including ICH-GCP, 21 CFR Part 11, and CDISC, Comprehensive understanding of the clinical drug and vaccine development lifecycle, Knowledge of medical terminology, anatomy, and physiology, project management and organizational skills
Nice to Have
Basic knowledge of PL/SQL and SAS, Familiarity with EDC platforms such as InForm, Rave, Veeva, Oracle Clinical (OC), e-Diaries, and e-Source systems, organizational, prioritization, and time management skills with keen attention to detail, Excellent interpersonal, teamwork, and communication skills with the ability to work effectively in a global environment, Adaptable and results-oriented professional with a problem-solving mindset and ability to learn quickly
What You'll Do.
Lead end-to-end clinical data management activities
Ensure high-quality data delivery
Ensure regulatory compliance
Ensure operational excellence
Partner with clinical operations
Partner with biostatistics
Partner with programming
Partner with medical writing
Partner with external vendors
Support timely study execution
Support database delivery
Manage multiple priorities
Communicate effectively
Collaborate across global teams
Support process improvements
Support vendor oversight
Support mentoring initiatives
Contribute to GSK’s mission
Define and execute Data Management strategy
Manage interim and final cleaned database locks
Archive Data Management documents
Archive study databases
Provide clinical data to study sites
Lead DS&M operational study activities
Serve as single point of contact
Conduct sponsor oversight
Ensure protocol training
Provide Data Management operational input
Create or review study-level timelines
Ensure adherence to timelines
Act as first point of escalation
Ensure compliance with GSK SOPs
How You'll Work.
Team & Collaboration
Partner closely with clinical operations, biostatistics, programming, medical writing, and external vendors; Collaborate across global teams; Work effectively in a global environment
Communication Scope
Communicate effectively; Excellent communication skills
Process & Methodology
project management and organizational skills, organizational, prioritization, and time management skills
Full Job Description
Are you ready to contribute to 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 Lead 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 Lead, 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. *****
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