7 years relevant experience in scientific or clinical environment
Thorough understanding of regulated clinical trial environment
In-depth knowledge of drug development process
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, initiation, and maintenance of clinical trials while ensuring compliance.
The position requires determining regulatory strategy, identifying complexity, and offering practical solutions to support bid processes and site activation plans.
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 scientific or clinical environment
Thorough understanding of regulated clinical trial environment
In-depth knowledge of drug development process
Proficiency in using systems and technology to achieve work objectives
Good regulatory and technical writing skills
Strong knowledge of Clinical Practice (GCP) and ICH guidelines
Nice-to-have
Experience mentoring and coaching colleagues
Ability to develop long-standing relationships with customers
Experience delivering presentations to clients and professional bodies
Creative problem-solving for regulatory challenges
Collaboration across multi-regional and multi-protocol programs
Key Requirements
Bachelor's Degree in Life sciences or related field
7 years' relevant experience in a scientific or clinical environment