Manager - Clinical Trail Transparency

Job description

Nombre del sítio: Bengaluru Luxor North Tower
Fecha de publicación: Feb 23 2024

rive end to end process delivery and improvements in the area of regulated and policy driven clinical disclosures and data sharing. Serve as a single-point of contact for project teams and functional matrix teams for questions related to Data Disclosure. Assess studies for disclosure and patient level data sharing requirements and guide study teams through the achievement of complete, consistent and timely disclosure and listing of studies in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register and Data sharing websites (such as Clinical Study Data Request (CSDR)). Ensure timely, consistent and accurate delivery of data disclosure artefacts (e.g. protocol and result summaries, full protocols, reporting and analysis plans and clinical study report synopses) to external registers e.g. ClinicalTrials.gov, EU Clinical Trials Register and GSK/ViiV Study Register, and to other national registers, as required. Collaborate with a team of recognized subject matter experts to ensure quality of output. Work with outsourced resources (platforms, consultants) to ensure resources to address workload beyond FTE capabilities. Supervise and monitor delivery of the documents amongst the different Service providers involved. Coordinate workload distribution and establish/ maintain a robust communication interface across all people involved in the delivery of the documents. Act as primary point of contact for service provider(s). Monitor CRO performance. Supervise quality of output delivered by individual members of the team Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translates into GSK’s Clinical Trial Disclosure and Transparency strategy. Promote 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. Proactively identify business transparency risks and propose and implement strategies to manage the implications of these risks on the business. Support risk management framework implementation, including risk identification, assessment and prioritisation and the definition of mitigation plans. Drive 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).

Drive end to end process delivery and improvements in the area of regulated and policy driven clinical disclosures and data sharing. Serve as a single-point of contact for project teams and functional matrix teams for questions related to Data Disclosure. Assess studies for disclosure and patient level data sharing requirements and guide study teams through the achievement of complete, consistent and timely disclosure and listing of studies in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register and Data sharing websites (such as Clinical Study Data Request (CSDR)). Ensure timely, consistent and accurate delivery of data disclosure artefacts (e.g. protocol and result summaries, full protocols, reporting and analysis plans and clinical study report synopses) to external registers e.g. ClinicalTrials.gov, EU Clinical Trials Register and GSK/ViiV Study Register, and to other national registers, as required. Collaborate with a team of recognized subject matter experts to ensure quality of output. Work with outsourced resources (platforms, consultants) to ensure resources to address workload beyond FTE capabilities. Supervise and monitor delivery of the documents amongst the different Service providers involved. Coordinate workload distribution and establish/ maintain a robust communication interface across all people involved in the delivery of the documents. Act as primary point of contact for service provider(s). Monitor CRO performance. Supervise quality of output delivered by individual members of the team Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translates into GSK’s Clinical Trial Disclosure and Transparency strategy. Promote 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. Proactively identify business transparency risks and propose and implement strategies to manage the implications of these risks on the business. Support risk management framework implementation, including risk identification, assessment and prioritisation and the definition of mitigation plans. Drive 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). Develop and maintain knowledge and expertise in Data Disclosure environment (Publications and Data Disclosure). Partner with key internal stakeholders to strengthen ensure that GSK practices for Policy requirements are in line with relevant internal and external requirements.

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

  

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