Data Sharing Specialist

Location

Bangalore | India

Job description

Site Name: Bengaluru Luxor North Tower
Posted Date: Mar 5 2024

Job Purpose :

SHaring Anonymised REsearch data (SHARE) is an initiative to provide greater access to anonymised patient-level data from published GSK sponsored clinical trials that have evaluated authorised or terminated medicines or vaccines.  This initiative is a key component of GSK’s objectives of Building Trust and being Transparent with the public regarding our Human Subject Research.

The Data Sharing role will report to the Head of Operations, Data Sharing & Anonymisation, and will work with her to manage the SHARE Requests.

This will involve the following:

• Working in the SHARE Request system (POMS) to review and respond to requests
• Working with the wider Data Sharing team to track the SHARE Requests from submitted to data and docs ready to access provided
• Working with the Data Sharing Analyst to ensure complete and correct information is provided and transferred from the SHARE Drop-box to the Transparency Repository and into the Data Access System. This includes the creation of Read-me files for each study package and QC of the transfer
• Managing the SHARE Enquiries (including off-line requests for publication authors) and running the weekly meetings to track progress of feasibility checking.
• Escalating issues to the DDRT Review Board.

Key Responsibilities :

• To manage the SHARE Proposals and Enquiries
• To review the SHARE Proposals and apply checks prior to escalation to Director
• To respond to researchers in the POMS system

• To chair the weekly Proposal tracking meetings to track the progress of requests through the data anonymisation and document redaction, signed Data Sharing Agreement, data and document transfer and account set up process.
• To chair the weekly Enquiry tracking meetings to track feasibility evaluations and raise issues for discussion and resolution.
• Input into the collection of metrics for reporting and workload management.
• To monitor the POMS system to ensure researchers are regularly updated of progress and escalate issues/bottle-necks as appropriate.
• Create the Read-me file for each study package and ensure it is accurately maintained to reflect any updates.
• Work with the Data Sharing Analyst to transfer agreed data and information to the researchers via the Data Access System,  ensure all researchers have a signed a data-sharing agreement prior to providing access to data, ensure that data and relevant documents are in the Transparency Repository and where necessary follow up with those responsible within GSK for providing the information.
• Ensure documentation (e.g. proposals, feasibility forms, data sharing agreements, correspondence) are appropriately archived upon completion of each request.

Job-Related Experience :

• Proven ability to manage complex requests
• In depth understanding of R&D and the clinical development process
• Experience in interpreting clinical data

• Expert knowledge of Clinical Disclosure of Human Subject Research Regulations

• Knowledge of data management processes
• Ability to communicate and work with a diverse team.
• Good team-working skills with ability to work with a high degree of independence
• Demonstrable ability to provide first rate customer service
• Ability to effectively manage conflicting demands in a high pressure, constantly changing environment
• Excellent verbal and written communication skills
•  Knowledge/awareness of GSK systems impacting data sharing processes

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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Salary