Work as Deputy Manager - Clinical Research in Piramal Life Sciences Limited
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 - Clinical Research
Supervising study conduct through active monitoring at allocated sites.
Coordination for all activities right from site selection to site close out for these sites.
Support measures for subject recruitment.
Assistance in audits and keeping the sites in a state of audit-readiness.
Ensure clean data collection and assist cleaning of the data through DCFs
Supply all logistics to sites and arrange for shipments back from sites including study medications.
Facilitate clearing of site invoices on a regular basis
Track all site documents and provide the same to sites in a timely manner
Plan, implement & overall management of clinical studies with the support from Project Managers
Tracking of study progress : identify & implement actions to keep projects on track
Interface with project team members – Regulatory, DM, Safety, Statistics
Interface with other departments for study set up and adequate study resources- Biomarkers, CMC, PK, Purchase, Finance, Legal etc.
Collaborate with vendors for the set up of the study.
Regular meeting with staff to monitor progress & share best practices
Organise & conduct Investigator Meetings
Preparation of site budgets & negotiation
Ensure quality according to GCP & SOPs
Intiation and follow up on significant/relevant project issues
Audit preparations & follow up actions on corrective plans
Co Monitoring Visits with CREs
On job training to Monitors & Class Room Training /Knowledge sharing
Coaching & motivation to clinical research staff
Contribution to appropriate technical training & individual personal development of staff.
Hands on experince in the field of clinical operations.
CRO bakground will be preferable.
Science / Pharmacy background with PG in clinical research.
Experince of Handling team.
Experience: 3 - 5 Years
Education: B.Pharm, M.Pharm, B.Sc, M.Sc, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 16th July, 2011
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