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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 Senior Specialist role will report to the Head of PLS and Data Sharing team, and will work with her to manage the SHARE Requests.
This will involve the following:
Working in the SHARE Request system 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
Managing the SHARE Enquiries (including off-line requests for publication authors) and running the weekly meetings to track progress of feasibility checking.
Checking research proposals received via the portal are complete and maintain highest-level of oversight of all requests. This will involve managing the SHARE Request system to review and respond to requests from researchers and managing enquiries (including off-line requests).
Escalating issues to the DDRT Review Board as required.
Interactions with senior stakeholders on a regular basis for their inputs of the Data Sharing activity.
Proactively identifying risk and areas for process improvement for data sharing process.
Key Responsibilities:
To manage the SHARE Proposals and Enquiries
To manage SHARE listings
To review the SHARE Proposals and apply checks prior to escalation to Senior Stakeholders
To respond to researchers in the designated system
To chair the weekly Proposal tracking meetings to track the progress of requests, 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 system to ensure researchers are regularly updated of progress and escalate issues/bottle-necks as appropriate.
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
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.
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