Project Manager@ Croissance Clinical Research Pvt Ltd, (Experience 3-4 yrs), Hyderabad "P"

Job Description

Provide training for SI / CRA / CRC / QA / Clinical Research Assistant.
Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient & compliant clinical operation of the CR
Assist the medical & clinical oversight of all aspects of function & work performed within the CR.
Work directly with clinical research personnel in reviewing lab data, performing physical examinations (including neurological assessments), medical histories, & evaluation of inclusion/exclusion criteria for study volunteers.
Support the implementation & application of Phase I, Phase II, Phase III, and Management System in the CR.
Participate in the review of individual adverse event reports for accuracy & clinical importance, & characterizes their relationship to the study drug, severity & seriousness. Liaising with medical consultants and client study team members as necessary, especially in the area of medical safety.
Participate in the review of source data and/or data listings of safety data, including adverse experiences, lab data, ECGs & vital signs data, to establish the presence or absence of abnormal trends, & if noted, follow-up as appropriate with the CR clinical team
Participate in the team reviews of proposed studies.
Support the drafting of informed consent documents, especially safety/risk sections.
Assist in conjunction with Clinical Team Leader, writing annual, and final clinical study reports and clinical sections of regulatory filings

Requirements

Minimum 3-4 Years of working experience as a Project Manager in any Clinical Research /Medical Device/ Pharmaceutical company.
Should be residing in Hyderabad currently.
Should be willing to join immediately.
Freshers please do not apply

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