Study Start-Up Operations Lead at GlaxoSmithKline (GSK)

Responsibilites:

• Plan and manage site selection and feasibility activities in collaboration with global and local colleagues.
• Prepare and Coordinate regulatory authority and ethics committee submissions and respond to queries.
• Negotiate study budgets, through to contracting
• Maintain transparent updates to study teams and stakeholders on start-up progress and risks.
• Contribute to process improvements and share best practices to strengthen start-up efficiency.

Why you?

       Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in life sciences, clinical research, pharmacy, nursing or a related field.
• Minimum of 3 years’ experience in clinical research or clinical operations focused on study start-up.
• Knowledge of local South African regulatory and ethics processes and ICH-GCP principles.
• Experience managing vendors, sites and multiple stakeholders in a matrix environment.
• Strong project management skills, including planning, tracking and reporting study milestones.
• Clear written and verbal communication skills in English and ability to work on-site in South Africa.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Advanced degree in life sciences or clinical research.
• Experience working in global pharmaceutical or vaccine clinical programmes.
• Familiarity with trial master file systems and clinical study systems.
• Prior experience negotiating site contracts and managing start-up budgets.
• Demonstrated ability to lead local teams and coach colleagues.
• Practical problem solving and documented experience implementing risk mitigation plans.