Are you a strong global clinical trials project manager who also enjoys growing and developing clinical operations teams? We've got a great role, partly office based in London. Our client focuses on Haematology and Cardiovascular projects and currently have new studies in start-up phase with the current projects sponsored by one of the biggest names in the pharmaceutical industry. 

The role provides a great opportunity to manage and develop a study team and outsourced service provider in global cardiovascular clinical trials and observational / real world evidence RWE studies. This is a great opportunity to make the role your own and to join a dynamic organisation where you can input and see the difference that you can make to the organisation.

Key responsibilities

• To lead all global studies and manage local/ regional Study Management Teams in implementation of clinical trials, ensuring the studies are performed and conducted in compliance with ICH-GCP guidelines,  SOPs and all applicable regulatory requirements for the allocated study
• Liaise and develop site networks with the site management tgeams
• Study oversight and status reporting study targets discussed and agreed; includes the development of study timelines, communication, risk and quality plans, team training and oversight
• Accountable for status of study/ies communicated regularly with study team and management and unresolved issues escalated appropriately
• Ensure specific and robust contracts are set up
• Protocols developed in conjunction with Chief Operating Officer and Investigators
• Attendance of and contribution to Investigator meetings
• Site and outsourced CRO staff trained in protocol specific procedures
• Management of ethics, regulatory requirements and local applications
• Liaison with external customers e.g. Steering Committees, Investigators, Study Nurses and Clinical Trial Pharmacists etc.
• To provide the day-to-day operational management of CROs and vendors ensuring delivery against contracted scope of work for the allocated region
• Plan and manage study budget

Desired Skills and Experience

• Proven clinical trials project management and leadership experience
• Life science or other relevant degree
• Excellent organisational skills
• 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 cardio vascular disease and treatment

Candidates must be experts in clinical research and be able to work 3 days/ week in the London office

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