The primary function of the Executive - Clinical Development is to plan and conduct clinical trials for QED; to produce clinical trial documents such as protocols, investigator brochures, study manuals, monitoring plans, etc.
Job Responsibilities
Manage clinical trial sites by performing routine monitoring visits to ensure
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- The trial is carried out in accordance with the GCP guidelines ,company SOPs and currently approved protocol/amendment(s)
- Progress of the project
- Enrollment targets are met
- The rights and well-being of human subjects are protected
- Reported trial data are accurate, complete and verifiable from source documents
Recruit Investigators and negotiate budgets for participation in clinical trials
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Review/Obtain
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- Draft protocols for completeness and feasibility
- Regulatory and administrative documents from the trial sites for completeness
Develop (for the conduct of the clinical trial)
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- Case Report Forms
- Source document templates
- Regulatory templates
Prepare/Process
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- (Serious) adverse event reports
- Project status reports for management
- Clinical study reports at the end of the study
- Presentations for Investigator meetings
- Participate in company required training programmes
- CRequired overnight travel is approximately 40%
Qualifications/Experience
- M.Pharm./MBBS/BDS/PhD (Life Sciences) and two (2) years of direct work experience in clinical trial monitoring including site management.
- Experience to include actual on-site monitoring of clinical trials, PSSVs, Site closeout visits, conducting feasibility studies.
- Outstanding communication skills (both verbal and written) are a must to be successful in this role.
- Demonstrated expertise in using the Microsoft Office products for presentations, documentations, preadsheets.
