Sr. Executive / Deputy Manager Job Clinical Data Managment at Piramal Life Sciences Ltd.

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. PLSL is focused on four therapeutic areas – Cancer, Diabetes, Inflammation and Infectious Diseases. The Company has a pipeline of fourteen compounds, including four in clinical trials. PLSL’s lead chemical compound, a Cdk-4 inhibitor, has completed two Phase I studies and is being tested in another Phase I/II trial for Multiple Myeloma. PLSL has drug discovery and development agreements with Eli Lilly & Company and Merck & Company, two of the leading pharmaceutical companies in the world.

Desired Candidate Profile

• Graduate or postgraduate degree in a scientific discipline with a background in biological sciences preferred.
• At least three years of experience in clinical data management in a pharmaceutical or CRO environment
• 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

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

Experience : 3 – 5 Years
Location : Mumbai
Contact Details : Piramal Life Sciences Ltd.
Website : http://www.piramallifesciences.com/
Interested candidates can send their resume to the following E-mail : research.recruitment@piramal.com
Address : Piramal Healthcare Limited
1, Nirlon Complex, Off W. E Highway,
Goregaon East
MUMBAI,Maharashtra,India 400063
Compensation  : Rupees 3,00,000 – 5,00,000

Deadline : 16.07.2011

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