Executive - Clinical Development QED Pharmaceutical Services
QED Pharmaceutical Services
Office Location
Full Time
Experience: 2 - 2 years required
Pay:
Salary Information not included
Type: Full Time
Location: Hyderabad
Skills: Protocol Development, adverse event reporting, project status reporting, Site Management, Feasibility studies, Communication skills, Clinical trial planning, clinical trial conduct, Investigator recruitment, Budget negotiation, Regulatory documents review, Case Report Forms preparation, Clinical study reporting, Presentation preparation, Microsoft Office proficiency
About QED Pharmaceutical Services
Job Description
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 * 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 Review/Obtain * 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 Regulatory templates Prepare/Process * (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.,