19 March, 2022
About the job
- Job Description –
1. Completion of all study related documents.
2. Monitor the subject for their safety and wellbeing during their stay in the clinical facility.
3. Preparation of BA/BE and CT protocols, Informed Consent document, Investigator’s brochure and other study related documents.
4. Preparation of the clinical study reports.
5. Submission of documents for Regulatory and EC approvals.
6. Assist the PI/Study staff in conduct of clinical phase of BA/BE studies.
7. Maintaining the trial master files for BA/BE studies.
1) Plan information acquisition by identifying potential investigators, conducting pretrial site visits, training site staff, monitoring trail drug accountability; studying clinical requirements; evaluating resources.
2) Monitoring , Managing and assuring the completion of all aspects of clinical trials across functional departments and therapeutic areas on-time; on-budget, according to SOPs, ICH/GCP and all local regulation.
3) Responsible for the safety and proper conduct throughout the trial.
4) Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator.
5) Oversee the Site Initiation and Site Close out activities.
6) Preparing & Submitting of EC /DCGI submission / Essential Documents Preparation
7) Training the candidates on medical writing & Regulatory affairs
Apply through below link