Transparency Specialist

• The purpose of the role of the Transparency Specialist is to coordinate the delivery of activities related to clinical trial data disclosure in GSK R&D in the respective therapy area (Oncology, General Medicines, Specialty, Vaccines). The role is responsible to ensure consistent, timely and complete delivery of clinical documents and data related to GSK Sponsored human subject research e.g. protocol and results summaries, full protocols, reporting and analysis plans and clinical study reports, and patient level data, ensuring ethical and transparent disclosure of data in compliance with GSK Policy on Disclosure as well as external regulations in collaboration with a multidisciplinary team of experts across projects. The role will support the implementation of new processes to meet regulatory requirements related to transparency of clinical studies and other data disclosure deliverables.

  Key Responsibilities:

  Responsible for end to end delivery of disclosure documents in the area of regulated and policy driven clinical disclosures and data sharing. Deliver on complete, consistent and timely disclosure of documents in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register. Coordinate/ Author disclosure documents (protocol summaries/ results summaries) and ensure review and approval of the same by the stakeholders according to defined SOPs and operational guides. Ensure timely availability of data disclosure artefacts (e.g. redacted full protocols, statistical analysis plans and clinical study reports), as required by applicable external regulations/ internal company policies. Partner with clinical study team members to ensure disclosure requirements are addressed early during the process of protocol development. Review protocol/ concept protocol as appropriate, for compatibility with requirements of external registers. Support consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements. Update Disclosure systems for disclosure activities planning, tracking and delivery. Ensures archival of final records in applicable systems for the posting of the documents on the required registries. Support risk management framework implementation, including risk identification, assessment and prioritization and the definition of mitigation plans. Support risk mitigation for identified business transparency risks and manage the implications of these risks on disclosure documents. Ensure compliance to organizational key performance indicators and monitor for continuous improvement in clinical data transparency and data sharing (e.g. Transparency Dashboard). Contribute to the development of training material for the business, clinical support services and service provider(s). Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translate into GSK’s Clinical Trial Disclosure and Transparency processes.

  Minimum Level of Job-Related Experience Required

  o    Broad scientific/ pharmaceutical industry background with at least 3 years of experience in scientific writing, regulatory writing or publications writing.

  o    Awareness of ICH-GCP guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)

  o    Experience with Clinical Trial Disclosure software solution(s).

  Experience in Pharmaceutical company environment and specifically in matrix organization.  

• Additional Job DescriptionAdditional Job Description

  The purpose of the role of the Transparency Specialist is to coordinate the delivery of activities related to clinical trial data disclosure in GSK R&D in the respective therapy area (Oncology, General Medicines, Specialty, Vaccines). The role is responsible to ensure consistent, timely and complete delivery of clinical documents and data related to GSK Sponsored human subject research e.g. protocol and results summaries, full protocols, reporting and analysis plans and clinical study reports, and patient level data, ensuring ethical and transparent disclosure of data in compliance with GSK Policy on Disclosure as well as external regulations in collaboration with a multidisciplinary team of experts across projects. The role will support the implementation of new processes to meet regulatory requirements related to transparency of clinical studies and other data disclosure deliverables.

  Key Responsibilities :

  Responsible for end to end delivery of disclosure documents in the area of regulated and policy driven clinical disclosures and data sharing. Deliver on complete, consistent and timely disclosure of documents in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register. Coordinate/ Author disclosure documents (protocol summaries/ results summaries) and ensure review and approval of the same by the stakeholders according to defined SOPs and operational guides. Ensure timely availability of data disclosure artefacts (e.g. redacted full protocols, statistical analysis plans and clinical study reports), as required by applicable external regulations/ internal company policies. Partner with clinical study team members to ensure disclosure requirements are addressed early during the process of protocol development. Review protocol/ concept protocol as appropriate, for compatibility with requirements of external registers. Support consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements. Update Disclosure systems for disclosure activities planning, tracking and delivery. Ensures archival of final records in applicable systems for the posting of the documents on the required registries. Support risk management framework implementation, including risk identification, assessment and prioritization and the definition of mitigation plans. Support risk mitigation for identified business transparency risks and manage the implications of these risks on disclosure documents. Ensure compliance to organizational key performance indicators and monitor for continuous improvement in clinical data transparency and data sharing (e.g. Transparency Dashboard). Contribute to the development of training material for the business, clinical support services and service provider(s). Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translate into GSK’s Clinical Trial Disclosure and Transparency processes.

  Minimum Level of Job-Related Experience Required

  o    Broad scientific/ pharmaceutical industry background with at least 3 years of experience in scientific writing, regulatory writing or publications writing.

  o    Awareness of ICH-GCP guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)

  o    Experience with Clinical Trial Disclosure software solution(s).

  Experience in Pharmaceutical company environment and specifically in matrix organization.  

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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