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.
Manage clinical trial sites by performing routine monitoring visits to ensure
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
Draft protocols for completeness and feasibility
Regulatory and administrative documents from the trial sites for completeness
Develop (for the conduct of the clinical trial)
Case report forms
Source document templates
(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%
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.
Posted 30+ days ago