Clinical Study Manager

Are you looking for a role that makes you feel valued, important and offers you the opportunity to make meaningful and transformative positive impacts on people's lives?

We are working with a global client whose ethos is plain and simple: we come to work to help be a part of a better future. If you are looking for a role within a business that inspires self-motivation, commitment and passion then you may just be the perfect missing piece to their team in Medical Clinical Operations.

Our client requires a Clinical Study Manager. They are committed to rewarding their employees for their impactful challenging work, so here are the perks:

• Competitive salaries / rates
• Excellent benefits package - employee health and wellbeing support, protection during life events, retirement plans and support
• Hybrid (2 days in office), providing flexibility when able
• Free parking onsite
• Company events
• Regular recognition and rewards for excellent work
• Personalised development and training opportunities

You will be the kind of person who wants to make a difference within your day-to-day work, but of course there are a few other requirements:

You will be a Clinical Study Manager with evidence of project management skills developed through leading successful study teams in all stages of clinical studies. The role focuses on the management of Investigator Initiated Studies (IIS) and managed Real World Evidence activities (RWE), and/or the country management of global studies. You will be a creative problem solver, critical thinker and create collaborative relationships across the organisation and with key stakeholders

Responsibilities

• Manage study teams and ensure team members are aware of their accountabilities, responsibilities and deliverables
• Ensure adherence to relevant guidelines (ICH GCP/GVP/GPP), regulations and Roche procedural documents. Always ensure study inspection readiness. Ensure the completion and finalisation of any corrective and preventive action plans resulting from site audits and inspections
• Maintain study plans and systems, including study documentation and track study metrics.
• Maintain study budgets and approve invoices, identify and communicate any issues/variances with study budgets with action plans for resolution. Review and negotiate work orders and study agreements, as applicable
• Manage study feasibility and site selection as well as site relations
• Supervise study activities from site activation to clinical closure including monitoring tasks and training
• Accountable for vendor study deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Maintain oversight of vendor performance and issues, and ensure vendors receive appropriate training
• Oversee the maintenance of drug supplies and resolution of issues
• Accountable for the tracking of HA and EC approvals, as applicable

Qualifications

• A clinical study manager professional with experience in managing investigator initiated and non-interventional studies.
• University degree in biological science is required.

Location: Welwyn (2days in office & 3days at home)

Salary: £450 - £500 UMB or £339.27 - £376.97 PAYE basic (excluding holiday pay)

Full Time: Monday - Friday, 37.5 hrs per week

Temporary: 6-12mth contract

For more information about this Clinical Study Manager role, please contact Chloe at Clearline Recruitment.