Job Description
Vacancy for Clinical Trial Transparency Associate at GlaxoSmithKline Pharmaceuticals Ltd. The purpose of the role of the Associate, Clinical Trial Transparency is to support 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 provide technical and Administrative support for the 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.
Job Title/Position:
Clinical Trial Transparency Associate
Job Overview:
Job vacancy for life science, biology, chemistry, biochemistry, pharmacology, pharmacy
Job Location:
Karnataka – Bengaluru
What are the Key Responsibilities?
• Support the operationalization of public disclosure requirements by coordinating the administrative/technical and nonscientific process for the delivery of disclosure content.
• Ensure maintenance of CTT timeline and workload planning / tracking tools, their timely updates and communication with Therapeutic area teams to support on-time delivery of CTT activities
• Collaborate with team members internal and external to CTT to receive and share clinical study-level information (eg: study status reports, Issue reports from public registers, study data maintenance reports from Disclosure systems) that are critical to CTT delivery.
• Support CTT Leads in the Disclosure maintenance updates to Regulated public registers (Clinicaltrials.gov, EU PAS Register) via the Disclosure system
• Work in close collaboration with other functional representatives to track cross-functional input for key CTT delivery
• Update Disclosure systems for regular study-level updates. Ensure archival of final records in applicable systems for the posting of the documents on the required registries.
• 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).
• Ensure proper documentation and archival support, timely implementation of audit findings and observations
• 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.
What are the Educational Qualification(s) for this position(s)?
Bachelor’s Degree in life science, biology, chemistry, biochemistry, pharmacology, pharmacy, other relevant experience
What is the Experience Required for this Job?
• At least 1-2 years of experience in in a Pharma/clinical trial environment is an asset
• 1-2 years of experience in an environment associated with Clinical Trials Disclosure and/or of the publishing environment is an asset
What are the Preferred Skills required for this Job/Position?
• Need to understand the business principles and processes of CTT and be able to acquire knowledge in an independent and fast manner
• Strong communication skills
• Experience in process improvement/quality management is an asset
• Experience in Pharmaceutical company environment and specifically in matrix organization is an asset
Related:
Vacancy for Junior Scientist at Sami-Sabinsa Group Limited
