7 years relevant experience in clinical environment
Thorough understanding of regulated clinical trial environment
Proficiency in ctms and project tracking tools
The role involves directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs
Job Summary
The role involves directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs.
Candidates must provide specialist regulatory and technical scientific support to facilitate efficient business development and study initiation while ensuring compliance.
The position requires determining regulatory strategies, resolving complex challenges, and collaborating across regions to deliver agreed project scopes.
Matching Summary
The role involves directing and managing the delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs.
Skills & Requirements
Must-have
7 years relevant experience in clinical environment
Thorough understanding of regulated clinical trial environment
Proficiency in CTMS and project tracking tools
Strong knowledge of GCP and ICH guidelines
Experience with international regulatory submissions
Nice-to-have
Ability to mentor and coach colleagues
Experience developing client relationships
Strong technical and administrative writing skills
Creative problem solving for regulatory challenges
Experience presenting to professional bodies
Key Requirements
Bachelor's Degree in Life Sciences or related field
7 years' relevant experience in a scientific or clinical environment
Demonstrable experience in an international role
In-depth knowledge of drug development process
Proficiency in using systems and technology to achieve work objectives