Clinical Project Lead

Are you a Clinical Project Manager/Lead with experience working with clients to ensure studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory guidelines?

Our client has an extensive global network of sites and they provide clinical trials to a range of sponsors across various therapeutic areas, with a main focus on cardiovascular, haematology and oncology.

Note this is a permanent full-time position working directly for our client in Central London. They operate a hybrid working policy and there is a requirement to be in the office 3 days per week.

Key Responsibilities:

• Lead global study management teams in the implementation of clinical trials ensuring compliance with ICH-GCP guidelines, SOPs, and all applicable regulatory requirements.
• Create project, quality, operational and risk plans, and metrics reports to ensure the successful delivery of high-quality project services and deliverables.
• Create and manage study budgets and resources, working closely with the finance department to provide study finance oversight.
• Serve as the primary escalation point for assigned projects, assess/mitigate risks, and help plan timelines for deliverables.
• Collaborate with the operational team to lead the delivery of training of sites ensuring that study team members are fully trained to perform their duties in accordance with Company/Sponsor SOPs.
• Drive communication with sponsors, partners, and key customers e.g., Steering Committees, Investigators, Study Nurses, and National Lead Investigators as required.
• Oversee the negotiation and execution of contracts and management of vendors ensuring delivery against contracted scope of work for the allocated region.
• Oversee regulatory and ethical submission and compliance, with a focus on local markets (complying with all applicable laws and regulations of each country).
• Perform other relevant duties as directed by management.

Desired Skills and Experience:

• Proven clinical trials project management and leadership experience.
• Life science or other relevant degree.
• Excellent organisational, presentation, supervisory, and interpersonal skills.
• Some experience in CPMIII/Global Project Management role.
• Proven ability to develop and update working practices.
• Flexible and effective project management, communication, and negotiation skills.
• Ideally experience overseeing outsourced CRO work.
• Ideally a strong understanding of cardiovascular disease and treatment.

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