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Role Summary: The Programme Leader is responsible for driving cross functional execution of clinical development programmes encompassing clinical studies. The initial focus of this role will be to lead X-Ray/CT contrast media programmes. Develop the integrated project plan and lead the team to successfully deliver all objectives.
Essential Responsibilities: Work closely with internal Clinical Project Managers, Medical Directors and Imaging Scientists to define the clinical development plans and milestone deliverables. Plan and oversee all aspects of clinical studies from feasibility to clinical trial reporting, according to the Clinical Development Plan and in compliance with Good Clinical Practice, Standard Operating Procedures, Corporate Policies, Guidelines and internal standards.
Responsible for managing, maintaining and accurately forecasting the project team resource requirements, clinical project subject enrolment and timelines, ensuring high quality image data is generated.
Accountable for oversight of external service providers, external scientific advisory boards or key scientific advisors to ensure their optimal on-time and within budget performance, quality of all deliverables and fulfilment of contractual obligations.
Ensures that all aspects of clinical trials, such as laboratories, service providers, and investigational medicinal product supply are appropriately enabled to commence work within the agreed timeframe and to the applicable regulatory/legal requirements and also ensures compliance in interactions with Healthcare professionals in accordance with company and national policies.
• Programme activities (internal and external) and milestones are planned, agreed and achieved according to the overall development plan; • Lead cross-functional programme activities; • Forecast and track internal and external resources and materials; • Manage the conduct, completion, recording and reporting of assigned clinical trials to ensure they are carried out according to relevant GCP standards and regulatory/legal requirements; • Responsible for the timely and accurate completion of study documentation; • Identify risks in meeting project milestones and to address resolutions; • Liaise with related functions/departments, e.g. Biometrics, Clinical Study Supplies, Imaging Technology, Regulatory Affairs; Medical Affairs, Portfolio/Program Management, Quality Assurance; Pharmacovigilance; Finance; Contracts; Legal and Compliance; • To participate in the selection of external providers of clinical services.
Qualifications/Requirements: • Scientific degree in Natural/Life Science or equivalent knowledge & experience; • Significant Pharmaceutical, Biotech, CRO or Medical Device industry experience; • Significant experience in GCP Clinical trials, preferably as a Clinical Project Manager; • Experience in working with outsourcing of clinical trials to CROs; • Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion • Excellent interpersonal, organization, communication, & influencing skills, able to work with internal and external stakeholders • Experience managing complex projects and/or across global regions desirable; • Good team player with global mindset; • Ability to work independently and with rigor; • Good process knowledge, experience, and skills; • Customer savvy and understanding of industry environment; • Technically savvy with experience in risk management; • Must be willing to travel as required;
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
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