Pharma jobs

R
OPENING AS Medical Officer - Clinical Research @Yuchra

Company Name
Yuchra

Locations
Delhi
Experience
3 - 8 years

Keywords / Skills

"clinical research", "medical monitoring", "clinical trial"

Education
MBBS, MD/MS

Function
Pharmaceutical/ Biotechnology

Role
• Clinical Research Scientist
• Medical Affairs Manager


Job Responsibilities:

*Development, implementation and monitoring of clinical trials and studies and ensure that Good Clinical Practices is followed. 
*Involved
in managing large scale clinical trial projects, monitoring 
investigator sites, reviewing protocols, participating in proposal 
meetings and preparing and reviewing reports
*Development of Standard Operating Procedures 
*Organizes
investigators' meetings and train the investigator site in Good 
Clinical Practices compliance/process improvement/medical aspects.
*Writing
of New Drug Applications protocols, case report forms, informed consent
forms, Standard Operating Procedures, medical reports, efficacy and 
safety summaries for clinical trials to international standards.
*Preparation of Grant submissions, budgets and contracts.
*Conducts
site visits for medical oversight including pre-study, at study 
initiation, at regular intervals during the study and at study closeout.
*Monitors
investigator performance and adherence to protocol and proactively 
addresses conduct issues and enrolment problems, as necessary. 
*Interact with data management to plan data entry and analysis.
*Ensure timely completion of trials.
*Ensure
that all clinical research activities are in compliance with current 
local and international regulations, laws, guidance (e.g. FDA, ICH 
etc.), Good Clinical Practices, company standards and the Principles of 
Medical Research.
*Plans clinical programs and develops a timetable, budget and resource analysis for programs and personnel administration.
*Verifies that the investigator follows the approved protocol, GCP's and applicable regulatory requirements.
*Verifies that source data/documents and other trial records are accurate, complete, and maintained.
*Reporting of Adverse events, Serious Adverse events

Required Experience:
MBBS /MD with good experience in clinical research and medical monitoring.

Required Skills:
*Ability to travel upto 40-60% of the time.
*Excellent organizational skills, ability to manage time effectively and work independently. 
*Project management skills.
*Conversant with scientific writing

.