Contract duration: 12 months
Rate: £419.46 per day PAYE
Location: Uxbridge (hybrid role - 3 days on site, 2 days remote)
Key Responsibilities
• Manage assigned clinical studies or components of larger global studies within designated geographical regions.
• Act as the key operational contact for assigned studies, overseeing site evaluation, initiation, monitoring and close-out activities either directly or through CROs.
• Support and manage Contract Research Organisation (CRO) and vendor activities, ensuring deliverables are met.
• Define and develop study logistics and clinical study plans to achieve project objectives.
• Manage study timelines, documentation, and stakeholder communications.
• Lead or participate in regional project meetings and cross-functional discussions with internal teams and external partners.
• Provide oversight of study sites and review regulatory documentation to ensure compliance with protocols, SOPs, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Contribute to the development of study protocols, informed consent forms, study plans, and presentations.
• Assist in the preparation of safety, interim, and final study reports and resolve data discrepancies where required.
• Identify and proactively address operational challenges to maintain study delivery against timelines and budgets.
• Collaborate with cross-functional teams to achieve study goals and objectives.
• Support the training and development of new or less experienced team members.
• Participate in process improvement initiatives and contribute to the development of tools and SOPs that enhance operational efficiencies.
• Represent Clinical Operations at internal and external meetings when required.
Requirements
Education and Experience
One of the following:
• PharmD or PhD with a minimum of 2 years' relevant clinical or life sciences experience.
• MA or MS with a minimum of 3 years' relevant clinical or life sciences experience.
• BA, BS or Registered Nurse qualification with a minimum of 3 years' relevant clinical or life sciences experience.
In addition:
• Several years of clinical or related experience within the life sciences sector.
• Experience leading or managing clinical studies and project teams.
• Experience managing the work of external vendors and CROs.
• Strong understanding of full clinical study lifecycle management, from study start-up through to close-out.
• Advanced knowledge of clinical study management best practices and tools.
• Thorough understanding of protocol requirements and the ability to interpret and communicate these effectively.
• Excellent knowledge of FDA, EMA, ICH-GCP guidelines, and other applicable global regulatory requirements.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK
Interested candidates should submit an updated CV
Please click the link below to apply.
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert
Salary description
£419.00 - £419.00 per day