Senior Clinical Study Manager

Senior Clinical Study Manager

UK

As the needs for clinical trials are rapidly increasing across Europe, one of my clients in the CRO sector are looking to once again expand their clinical team across the UK.

This senior clinical study manager will be reporting to the head of clinical operations as well as supporting and mentoring the junior employees of the business.

Working as a CSM, you’re main responsibilities will be:

• Overseeing the clinical projects across the UK to ensure they comply with GCPs and SOPs regulatory requirements
• Update and check the Trial Master File (TMF) of the studies as well as ensuring that the site TMF are checked by the monitoring team according to CRO and Sponsor procedures
• Review and approve the Investigator’s Folder and Trial Master File prototype
• Developing the clinical study protocol and ensure input, review and finalisation occurs within budget and timelines
• Lead the clinical team during projects as well as training CRAs and supporting the CPMs
• Ensure that the monitoring activities are conducted as per monitoring plan requirements

Requirements:

• Ability to work independently
• Work in the office 2 days a week and 3 weeks working from home
• Life science degree
• Familiar with ISO 14155, and Medical Devices Legislation Values
• Strong leadership skills
• Background as CSM or similar for a minimum of 3 years.

I am setting some time aside to discuss this role with people who are passionate about clinical research and who want to better their career in the UK.

Take that next step into study management and reach out to me today:

?+44 1273 952187

? roxanna.keshavarz@rbwconsulting.com