Data Lead

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D


Position Summary

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

Basic Qualification

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

Previous Experience Required

• 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

Preferred Qualification

• 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.

Skills

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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.

Inclusion at GSK:

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.