Hobson Prior are looking for a Global Study Leader to join a leading biopharmaceutical organisation who provide pioneering medicines to patients all over the world. This role will be responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines.

Job Responsibilities:

• Accountable to lead the delivery of the clinical study from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards.
• You will contribute to the preparation and delivery of study documents.
• Responsible for the oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs.
• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate manager or CRO representative.
• Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment.
• Implement agreed study level process and technology for Early Oncology clinical studies.
• Manage to the agreed study timelines, budget, and resource and ensure the update of appropriate systems.
• Accountable for the quality of study planning information into relevant planning systems.
• Guide the study team in the development of outsourcing specifications and vendor selection.
• May manage the vendors throughout the life of assigned clinical trials based on delivery model.
• May convene and lead the cross functional study teams for Early Oncology Clinical studies based on delivery model.

Key Skills:

• Experience and strength in working and leading in matrix teams.
• Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict.
• Proven ability in problem solving and issues management that is solution focused.

Requirements:

• Bachelor's degree in related discipline, preferably in medical or biological science.
• Minimum of 5 years progressive experience in clinical research, with at least 3 years of clinical development project management experience or equivalent.
• Comprehensive knowledge of the clinical and pharmaceutical drug development process.
• Excellent knowledge of ICH-GCP principles.
• Extensive and proven experience in driving operational delivery to timelines, cost and quality.
• Proven experience leading delivery through internal and external organizations.
• Experience in providing clear requirements for external contracts.
• Experience in selection of external providers and development/review of contracts.
• Proven oversight of external providers.

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.