1. Set-up and monitor trials according to Company SOP’s, Country regulations and ICH GCP guidelines
2. To meet recruitment targets and study timelines
3. To conduct feasibility on new trials
4. To select & access investigators for suitability, experience & ability to meet recruitment targets
5. To develop key opinion leaders
6. To share feedback of information from Investigators and Key Opinion Leaders with the clinical trial Manager
7. To report to the clinical trial Manager the progress of the trials on a weekly basis
8. To report to the clinical trial manager on a daily basis any difficulties or problems discovered.
Key Job Dimensions
Line reports – None
Functional Reports –
Important business working relationships include Medical department, Sales & Marketing, pharmacovigilance and Regulatory Departments of the Sponsor Company.
Attributes / Experience Required:
- A background in science or paramedical area.
- Preferably two years direct clinical trial monitoring experience
- Excellent written and oral communication skills
- Motivated self-starter.
- Ability to work on own initiative and under pressure.
- Excellent communication and organisational skills with proven ability to interact well with Investigators, Site Staff, all levels of management and other staff.
- A clear understanding of Company SOP’s, regulatory and ICH GCP guidelines