Data Lead

 The Data Lead is responsible for overseeing the end-to-end DS&M study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.

Responsibilities

• Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include:
• Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
• Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
•  Interim and final cleaned database lock
• Archival of all DM documents in the eTMF
• Archival of the study database and provision of clinical data to the study site
• For an in-house study, leads the day to day DS&M operational study related activities, acts as a member of the study core team and provides sponsor oversight to the Functional Service Provider (FSP) working on the study
• For a study outsourced through Full Services Outsourcing (FSO), conducts & documents sponsor oversight of the end to end FSO study related activities.
• Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register
• Provides reports, status updates, feedback and advice to key study stakeholders on study progress.
• Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these
• Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity
• Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level
•  Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
• Develops and maintains excellent professional relationships with study team and other key stakeholders 

•  Bachelor’s Degree, in scientific or business discipline·      
• Post Graduate Degree in Scientific Discipline

• Experienced in Clinical Data Management processes, standards and clinical systems
• Project Management
• Exposure to Veeva, InForm, Rave, e-Diaries, e-Source is an added advantage
• Proficient in Microsoft exce and validation methodology
• Basic knowledge of PL SQL, SAS is an added advantage
• Understanding of general data flow & database architecture concepts
• Good understanding of regulations including ICH-GCP, 21 CRF part 11, CDISC requirement
• Comprehensive understanding of clinical drug /Vaccine development process
• Knowledge of medical terminology, anatomy and physiology
• Certification: CCDM (if present) added advantage

If you are excited about growing your career while making an impact on clinical data quality, we encourage you to apply. We look forward to hearing how you can bring clarity and commitment to our clinical data management team.

• Pharma and/or CRO experience.     
• Understanding of disease area.   
• Understanding of laboratory data.
• Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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