Consultant NCE CTA TMF Submission Coordinator
Site Name: India - Maharashtra - Worli Mumbai
Posted Date: Aug 28 2019
The Job holder works within the NCE CTA function to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role.
• Responsible for daily management of the CTA TMF Mailbox and support filing of CTA TMF artefacts.
• Ensuring keeping up to date with internal CTA & TMF landscape.
• Accountable for agreed tasks and projects.
• Ensure independent communication, with a range of internal GSK staff & external stakeholders, in support achievement of the assigned goals.
• Ensure compliance with GSK processes through timely action and completion of records in internal GSK systems.
• Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping.
• Accountable to the CTA Team Lead and Line Manager for overall work plans.
• May be accountable to Global Regulatory Leads or Regional Representatives for delegated tasks or definition of requirements within an agreed project.
May support coordination of CTA submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures.
• Knowledge and experience of filing artefacts per the DIA Trial Master File Reference Model.
• Knowledge of practical implementation of the European Clinical Trial Directive.
• Knowledge of clinical trial application process and review for countries outside Europe would be an advantage.
• Understanding of the use and importance of internal tracking to ensure compliance with reporting and other requirements for each study protocol.
• Pays attention to detail; is aware of the importance of accuracy and the need for compliance with internal and external policy and regulations.
• Sound interpersonal and communication skills to ensure sound level of engagement of others
• An ability to manage multiple tasks in parallel and organize time and actions within submission or project timeframes
• Able to work effectively in, and promote, sound team working across organizational boundaries
• Works co-operatively with others, individually or in teams, in order to achieve project or product goals.
• Takes time to reflect on own performance and learn from experience to improve overall performance and input to process improvements to benefit other projects.
• Ability to work in multiple IT systems (filing, tracking & repositories)
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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