Openings Openings Openings At Synergen Bio Pvt Ltd.
Position: Clinical Research Associate
Vacancies: 04
Qualification: B.Pharm, M.Pharm
Experience: 2-3 Years
Clinical Research Associates:
Ensure that the rights, safety and well-being of subjects in a clinical trial are respected
Identify and select the sites, to conduct the Evaluation visit, Initiation visit, Monitoring and Closure visits Ensure that all adverse events are accurately documented and transmitted
Review of all data collection folders (Case Report Form), comparing them with the original documents (reconciliation)
Manage and perform monitoring and site management activities related to clinical trials
Perform remote and on-site monitoring & oversight activities
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/
inspections and overall site performance share CV on-career@synergenbio.com, under email subject line mention "Applying for CRA position"
2) POSITION: MEDICAL WRITER
Vacancies: 03
Experience 2-3 Years
Qualification: B.Pharm, M.Pharm
JOB DESCRIPTION :-
Manage the writing, editing and reviewing of diverse regulatory & clinical documents for multiple projects in various stages, including clinical study reports (CSRs),
clinical trial synopses, study protocols, investigator brochures, informed consent forms, clinical data summaries, clinical modules, dossiers and other medical/ regulatory documents including SOPS.
Manage the writing, editing and reviewing of, publications, abstracts, manuscripts, Posters, DSURS, PSURS, PBRER, RMPs, and signal detection reports. Provide input to timelines for completion of clinical documents and ensuring delivery documents to meet the
timelines.
Review pertinent literature, evaluating its applicability and incorporating the information into clinical documents. Ensure that all clinical documents are produced according to appropriate SOPs, business practices and quality standard.
Interested candidates can share their resume on
career@synergenbio.com Under Email subject line please mention "Applying for Medical Writer Position"
