Business IntroductionAt 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&DPosition; SummaryThe Manager, Clinical Data Management is responsible for overseeing the end to end Data Strategy & Management (DS&M;) study related activities and is accountable for all Data Management study deliverables in terms of quality & delivery to plan. This role mentors other DS&M; team member(s) and acts as Subject Matter Expert.ResponsibilitiesAccountable for the end to end DS&M; study related activities in terms of quality & delivery to plan which include: o Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessmentso Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliationo Interim and final cleaned database locko Archival of all DM documents in the eTMFo Archival of the study database and provision of clinical data to the study siteAccountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of study (different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies)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 is the single point of contact for all the DM study related activities & mattersFor a study outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO), conducts & documents sponsor oversight of the end to end FSP/FSO study related activities and ensures training on the protocol to the FSP resources working on the studyProvides DM operational input into the study design, the protocol, study planning, study documents including the study risk registerProvides reports, status updates, feedback and advice to key study stakeholders on study progress.May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts.Creates or reviews study level timelines for DM deliverables and ensures teams adhere to thesePromotes the implementation of clinical data standards to increase consistency, efficiency & productivityActs 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 levelEnsures DM study deliverables are in compliance with GSK SOPs and regulatory guidelinesDevelops and maintains excellent professional relationships with study team and other key stakeholdersActs as a mentor for junior members of the DS&M; teamActs as a Subject Matter Expert supporting the implementation of recent processes, data standards, trainings, systems, vendor quality assessments, audits and inspectionsBasic QualificationBachelor’s Degree, in scientific or business disciplineThe individual in this role needs to be able to manage varied and multiple studies associated with the size and complexity of the clinical trial phases and Therapeutic areas. This requires a skilled, disciplined, organized and systematic approach as would be expected from individuals with this backgroundMinimum Level of Job-Related Experience RequiredPharma and/or CRO experience.Understanding of disease area.Understanding of laboratory data.Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPsPreferred QualificationExperience working with global suppliers/ partnerships to ensure deliverables are to the agreed standardDemonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets
- Operates across a global, complex organization. Includes applying the processes, methods, tools and approaches used to facilitate data management activities, and the day-to-day running of a project or study-aligned teamSupports capability build across the functionDevelops recommendations for study or project issue resolution
- Builds influential networks within the organization & study team members. Uses these relationships to generate buy-in and support for the project, Data Management Plan or equivalent, to ensure mutually advantageous resources and goalsEnsure sharing of knowledge and learning with the GSK Data Management Community
- Assists in operational excellence and data quality focus negotiations with vendors and strategic partners Communicates technical topics to a non-technical audience.Uses an extensive network within GSK and external to keep abreast of industry trends and be part of the development of those trendsCertification: CCDM (if present) added advantageHow to applyIf you want to grow your career while contributing to work that matters, please apply. We look forward to learning about your experience and how you would help improve clinical data quality and delivery.SkillsWhy 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 [email protected] to discuss your needs.Important notice to Employment businesses/ AgenciesGSK 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 [email protected], so that we can confirm to you if the job is genuine.

📌 Manager, Data Management (Bengaluru)
🏢 Glaxosmithkline
📍 Bengaluru