Executive - Clinical Development QED Pharmaceutical Services

2.0 - 6.0 years

0 Lacs

hyderabad, telangana

On-site

The primary function of the Executive - Clinical Development is to plan and conduct clinical trials for QED. You will be responsible for producing clinical trial documents such as protocols, investigator brochures, study manuals, and monitoring plans. Your job responsibilities will include managing clinical trial sites by performing routine monitoring visits to ensure that the trial is carried out in accordance with the GCP guidelines, company SOPs, and currently approved protocol/amendment(s). You will also be responsible for monitoring the progress of the project, ensuring enrollment targets are met, and protecting the rights and well-being of human subjects. Additionally, you will need to ensure that reported trial data is accurate, complete, and verifiable from source documents. You will be required to recruit Investigators and negotiate budgets for participation in clinical trials. You will review and obtain draft protocols for completeness and feasibility, as well as regulatory and administrative documents from the trial sites for completeness. In this role, you will develop Case Report Forms, source document templates, and regulatory templates for the conduct of the clinical trial. You will also prepare and process (Serious) adverse event reports, project status reports for management, clinical study reports at the end of the study, and presentations for Investigator meetings. Participation in company required training programmes is essential. Approximately 40% of the time, overnight travel may be required. To qualify for this position, you should have an M.Pharm./MBBS/BDS/PhD (Life Sciences) degree and two (2) years of direct work experience in clinical trial monitoring, including site management. Experience should include actual on-site monitoring of clinical trials, PSSVs, site closeout visits, and conducting feasibility studies. Outstanding communication skills (both verbal and written) are a must to be successful in this role. Demonstrated expertise in using Microsoft Office products for presentations, documentations, and spreadsheets is essential.,

Posted 2 weeks ago

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