Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs
Job Summary
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
Matching Summary
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
Skills & Requirements
Must-have
Site Activation Strategy
Regulatory Submissions
Clinical Trial Management
GCP and ICH Guidelines
Contract Negotiation
Nice-to-have
Mentoring and Coaching
Client Relationship Management
Cross-functional Collaboration
Problem-solving Skills
Key Requirements
Bachelor's Degree Life sciences or related field
7 years' relevant experience
International role experience
Proficiency in systems and technology
Understanding of regulated clinical trial environment