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Senior Transparency Specialist Data Sharing

External
GSK logoGsk · Bengaluru Luxor North Tower
Full-timeOn-siteToday
Clinical TrialsDocumentationProcess Improvement
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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.
  • 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

Requirements

  • Anonymization, Clinical Documentation, Clinical Trials, Communication, Data Sharing, Learning Agility, Pharmaceutical Industry, Research Publications, Strategic Thinking
  • Why GSK?
  • Uniting science, technology and talent to get ahead of disease together.
  • 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

Benefits

Health insurance

Additional Information

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.


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