Clinical Development Manager

The Clinical Development Manager (CDM) will be responsible for leading cross-functional teams in delivering quality clinical studies and/or tissue bank studies within the CUC with end-to-end involvement and oversight from protocol development, study set up, study execution, study closeout and final study report. The role is based within GSK's Phase 1 Clinical Pharmacology Unit (Clinical Unit Cambridge). You will collaborate with other functions both within the CUC and wider GSK departments, as well as third parties external to GSK.,

• Lead the operational delivery and quality of clinical trials and/or tissue bank studies within the CUC, ensuring compliance with ICH/GCP, regulatory, ethical requirements, and GSK written standards.
• Maintaining end-to-end oversight of study conduct and communications, including risk and issue management to make decisions which balance benefit/risk with a clear understanding of impact on project; takes actions to mitigate risk where appropriate.
• Developing, reviewing and/or enhancing the operational and scientific robustness of clinical trial documentation including Study Delivery Plans, Study Protocols and manuals, Informed Consent Forms, clinical study timelines, costing templates, and other study documents as required.
• Coordinating and submitting the required package of regulatory documents for approvals to conduct the clinical trial, e.g. Ethics Committee and Regulatory Clinical Trial Applications (CTAs), NHS R&D, and manage subsequent correspondence, approvals and amendments through to close-out of the clinical trial.
• Maintaining study documentation for the Investigator Site File for monitoring and inspection-readiness.
• Requires active partnership building and collaboration with other functions both within the CUC and wider GSK. Interact effectively across boundaries with functions using influencing and relationship-building skills.
• Managing and leading on multiple workstreams, alongside clinical trial management, and delivering to demanding deadlines., We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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• Bachelor of Science or equivalent, or professional qualification in a life science field.
• Experience of successfully leading on clinical study delivery as a study manager, clinical development associate, clinical trial coordinator or other similar role within a Clinical Pharmacology Unit.
• Able to demonstrate understanding of the drug development process, with particular expertise in early clinical development, clinical trials requirements and clinical trial terminology.
• Experience working within a GCP environment (or similar).
Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
• Excellent organisation and leadership skills in a matrix team environment.
• Ability to deliver to demanding deadlines, with an agile and flexible approach, whilst maintaining quality.
• Exemplary written and verbal communication.
• Able to build relationships in a dynamic and matrix environment, including navigating, influencing and communicating complex discussions and issues, encouraging alternative perspectives, managing change, and developing solutions.
  
  At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Find out more: Our approach to R&D. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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