Hobson Prior are currently working with a leading pharmaceutical organisation who focus on preventing, diagnosing and managing diseases. Our client is looking for a Country Study Manager to join them on a contract basis in Hertfordshire where you will provide leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management.

Job Responsibilities:

• Accountability and oversight for all assigned studies at regional/country level in accordance with the overall project plan, manages and maintains accurate country/study level plans.
• You will highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
• Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective.
• Interfaces with CRO Management regarding feedback on CRO staff performance as required.
• Plans and executes country study goals and commitments and ensures compliance to relevant processes.
• Coaches and provides support to responsible study team members.
• Partakes in overall Therapeutic Area support together with the therapeutic leads and country experts as required.
• Delivers study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level.
• Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
• Co-operates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.

Key Skills:

• Excellent decision-making skills.
• Strong communication skills.
• Ability to develop and leverage relationships within and across work groups to achieve results.

Requirements:

• University degree or equivalent; preferably in a medical/science-related field.
• Extensive experience and expertise in clinical research/development or related industry.
• Extensive experience in clinical trial project management.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.