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For Employers

Physician

Bio Scientific Research Laboratories (BIOSRL)

0 - 3 years

|

3 - 7 Lacs

Posted:4 days ago| Platform:

Apply

Skills Required

supervisor cvs data management compliance gcp compliance management database principal investigator medical writing logistics

Work Mode

Work from Office

Job Type

Full Time

Job Description

BABE and Phase Trials
ICH-GCP and ethical aspects for conduct of a clinical trial study

execution teams to work upon clinical studies across two different clinical study management

Providing valuable medical inputs to the Medical Writing team comprising of protocol writers and report writers
Organize and schedule activities from protocol writing, IEC submission and eCTD specification for study report submission

Manage a volunteer registration and management unit with a volunteer registration data base comprising

Establish firm execution systems and SOP's governing clinical execution aspects and completed studies with GCP compliance

Reporting recording and management of several adverse events in accordance with safety principles and regulatory guidance

Establish Adverse Event tracking system which aided in following volunteers who encountered adverse events

Devise strategies across sample processing area and ensure minimal logistics utilization for cold chain maintenance for samples

Establish eCRF documentation for source data management

Preparation of Patient Information Leaflets

Scrutinizing healthy volunteers for BA/BE study in coordination with Principal Investigator

Supervise day to day activity assigned to study personnel

Ensuring the proper functioning of Emergency care equipment s before study commencement and throughout study period

Supervise day to day activity assigned to study personnel

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Bio Scientific Research Laboratories (BIOSRL)

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