* Complete understanding of scientific rudiments and principles of Controlled Clinical Trials methodology and process
* Practical hands on experience in phase III Oncology, Nephrology, General Medicine and General Surgery trials.
* Good clinical knowledge and exposure to medical terminology, medications, and pharmacology.
* Practical knowledge on ICH / GCP guidelines; Schedule Y; Ethical principles; US FDA and European Union regulatory requirements.
* Experience in designing and developing contracts, agreements, SOPs, site files, trial master files, CRFs, study-specific logs, guidelines, manuals and reports.
* Capacity to plan and carry out pre-study, initiation, routine monitoring and c...
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