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Tuesday, June 29, 2010

Clinical Research Executive(Senior Executive)

Piramal Life Sciences Limited - “We dream of making a difference to the quality of life by reducing the burden of disease.” The community at Piramal Life Sciences Limited aspires to reach catalytic innovation to the broader masses, in India and across the world. 

DesignationClinical Research Executive(Senior Executive)
Job DescriptionThe candidate will be responsible for clinical trials in accordance with protocols, company SOPs, Schedule-Y and ICH- GCP guidelines, including - feasibility , sites selections, initiations, monitoring and close-outs. Documentation, data cleaning activities & obtaining necessary approvals would be part of the challenging activities of this job.

The primary responsibility for the position would be Site Monitoring, including the following:

• Perform study site qualification visits

• Conduct investigator’s meeting

• Perform site initiation visits

• Ensure regulatory documents are available, complete, current and submitted as per timelines.

• Conduct site study training.

• Perform regular monitoring visits to site, prepare monitoring reports and maintain audit readiness at the site level.

• Responsible for patient recruitment and providing alternative solutions

• To resolve all data queries or other study related queries from the site within stipulated timeframe.

• Conduct site close out and assure appropriate archival of controlled documents.

Desired ProfileThe candidate must have a bachelor’s degree (in pharma/science) with at least 2-3 years of working as a CRA in a pharma/ CRO/ biotechnology company and should have good communication skills.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop/computer are a pre-requisite for the post. Willingness to travel across the country, at short notice would be expected of the candidate.

Experience2 - 3 Years
Industry TypePharma/ Biotech/Clinical Research
Functional AreaHealthcare, Medical, R&D
EducationUG - B.Pharma - Pharmacy,B.Sc - Any Specialization
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization,PG Diploma - Any Specialization
LocationMumbai Suburbs
KeywordsClnical Research, site monitoring
ContactMs. Lourdes Nunes
1, Nirlon Complex, Off W. E Highway,
Goregaon East
MUMBAI,Maharashtra,India 400063


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