Job title: Coordinator, Clinical Trial Transparency
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Feb 23 2022 Job Purpose The purpose of the role of the Coordinator, Clinical Trial Transparency is to coordinate the delivery of activities related to clinical trial data disclosu
Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Feb 23 2022 Job Purpose 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. Key Responsibilities (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role. 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. Knowledge/Education Required Minimum Level of Education Required Area of Specialization Why is it required University Scientific Degree Master or equivalent professional experience Life sciences, biology, chemistry, biochemistry, pharmacology, Pharmacy, Clinical Research Need to understand the science behind the documents (protocol/results summaries/ study reports) (be able to participate in specialized scientific discussions) Need to be able to acquire knowledge in an independent and fast manner (Dependable self-starter). Need to be able to handle complex governance questions in a corporate setting. Preferred Level of Education Area of Specialization Why is it required Phd Life sciences, biology, chemistry, biochemistry, pharmacology, Pharmacy, Clinical Research Medical Governance qualification is an asset Need to understand the science behind the documents (protocol/results summaries/ study reports) (be able to participate in specialized scientific discussions) Need to be able to acquire knowledge in an independent and fast manner (Dependable self-starter). Need to be able to handle complex governance questions in a corporate setting. Previous Experience Required Minimum Level of Job-Related Experience Required Why is this level of experience required 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. The job-holder will interact with many different functions across GSK position holder needs to understand intimately the business needs and operating environment across the entire development organization legislation is complex and continually evolving. List below any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. 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. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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Location: Bangalore, Karnataka
Job date: Fri, 25 Feb 2022 23:36:26 GMT
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