Global Study Lead

An exciting contract opportunity within a groundbreaking big-pharma institution has become available! My client is looking for an experienced Global Clinical Lead to head up, manage and control their global clinical trials projects lasting 18months – 2 years. This is an excellent opportunity to project manage a range of highly important global early stage trials and making a huge difference in developing life-saving drugs within Cardiology, Renal and Muscular therapeutic areas.

Key responsibilities include:

• Lead and guide cross-functional study teams / oversee outsourced delivery activities to ensure progression of all global clinical studies to timelines, quality and budget
• Take responsibility for all communications and accountability for developing essential study documents
• Engage all external service providers ensuring adequate oversight is documented according to SOPs
• Develop and maintain study plans
• Overall accountability for all system utilization and risk management / risk mitigation as well as study budget management
• Oversee all quality issue reporting, ensure collaboration with all stakeholders and CRO
• Ensure compliance with governance controls
• Oversee individual performance of study members and ensure resource utilization
• Work on non-drug project work / identifying process improvements

Skills, Qualifications and Experience required

• Relevant Bachelors degree essential, advanced degree desirable
• Minimum 5 years experience in clinical research – 3 years of clinical development project management experience needed
• Strong knowledge of ICH – GCP as well as relevant regulatory / ethics requirements
• Recent global project experience within Cardiology, Renal and Muscular therapeutic areas.
• Strong problem solving ability, excellent attention to detail, excellent leader and multi-tasker
• Proven experience leading delivery through internal and external organisations
• Excellent collaborative communication skills

This is a fantastic opportunity which is a critical hire for my client, please send your CV and a cover letter to be considered for the role. Please allow 24 hours or 1 working day for me to review.