Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
Post: Deputy Manager/Manager - Clinical Research & Development (Group-Biostastistics Data Management)
Job Description:
• Review study documents and provide inputs towards the development of CRF
• Prepare Data Management Plans (DMP)
• Contribute towards the development of the database, help with the testing of data entry screens, and validation of edit check programs.
• Review CRF data for completeness, consistency and accuracy, identifying and resolving data discrepancies
• Manage the CRF and Data Correction Form (DCF) tracking, and query resolution process
• Contribute to database lock activities such as audits
• Work collaboratively with colleagues in biostatistics, data management, clinical research and operations to meet project deliverables with quality and within timelines
• Attend project teleconferences and meetings
• Contribute to the development of Standard Operating Procedures (SOPs) for the department
• Contribute towards ensuring that all necessary documentation is in place in accordance with GCP and Standard Operation Procedures (SOPs)
• Provide guidance to other colleagues in data management as required
Candidate Profile:
• Familiarity with Oracle Clinical and other clinical data management systems; knowledge of electronic data capture desirable.
• Understanding of Clinical Data Management processes and ICH GCP guidelines
• Good communication skills and ability to work in cross-functional teams
Additional Information:
Experience: Min. 3 Year
Location: Goregaon, Mumbai
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 16th March, 2014
Apply/Forward Your Resume at, research.recruitment@piramal.com
The subject may read 'Application for Database Designer- DBD01M'
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