GSK - Coordinator - Clinical Trial Transparency

Job description

Site Name: India - Karnataka - Bengaluru

Are you energized by a clinical education role that allows you to build industry-leading medical capabilities through an integrated professional development framework? If so, this Clinical Support Manager role could be an exciting opportunity to explore.

The Coordinator, Clinical Trial Transparency is responsible for coordinating delivery of transparency documents within each therapy area (Oncology, Specialty, Vaccines), through timely and complete delivery of protocol and results summaries, full protocols, reporting and analysis plans and clinical study reports, as required by regulations and policy, for submission to key external registers e.g. ClinicalTrials.gov, EU Clinical Trial Register and the GSK Study Register. The objective is to promote consistent process for disclosure activities throughout the global organization and ensure contribution to maintenance and improvement of processes for public disclosure function according to evolving requirements. The role will report into the Director, Clinical Trial Transparency.

The purpose of the role of the Coordinator, Clinical Trial Transparency is to coordinate the delivery of activities related to clinical trial data disclosure in GSK R&D in the respective therapy area (Oncology, 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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- 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.

- Partners with clinical study team members to ensure disclosure requirements are addressed early during the process of protocol development. Reviews 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.

Why you?

We are looking for professionals with these required skills to achieve our goals:

- University Scientific Degree Master or equivalent professional experience

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

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

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

- Experience in Pharmaceutical company environment and specifically in matrix organization.

- Knowledge and understanding of R&D environment, and applicable disclosure requirements.

- Operational knowledge and understanding of statistical concepts in clinical research.

- Proven sense of urgency.

- Excellent English language written and verbal communication skills in addition to proven negotiation skills.

- Ability to resolve problems with use of knowledge, information and networks in a flexible way and to be successful in a matrix environment.

- Self-motivated with the ability to work independently, to develop credibility with colleagues.

- Act as a role model in line with GSK core values and behaviours.

- Comfortable to evolve in changing and challenging environment.

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