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Saturday, May 28, 2011

Deputy Manager - Clinical Research 1 Opening(s) Piramal Life Sciences


Summary
 

Experience:
3 - 5 Years
Location:
Mumbai
Compensation:
Rupees 3,50,000 - 5,00,000
Education:
UG - B.Pharma - Pharmacy,B.Sc - Any Specialization,BDS - Dentistry,MBBS - MedicinePG - M.Pharma - Pharmacy,M.Sc - Any Specialization,PG Diploma - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Clinical Research Associate/Scientist
Functional Area:
Healthcare, Medical, R&D
Posted Date:
27 May

Desired Candidate Profile

Hands on experince in the field of clinical operations.
Hardworking, Adaptable.
CRO bakground will be preferable.
Science / Pharmacy background with PG in clinical research.
Experince of Handling team.

Job Description

Monitoring:

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
Leadership Role:

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.

Keywords: clinical operations, clinical research executive

Company Profile

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.

PLSL has been listed on the National Stock Exchange and the Bombay Stock Exchange since June 2008.
Contact Details
Company Name:
Piramal Life Sciences Ltd.
Executive Name:
Ravindra Dandekar
Address:
Piramal Healthcare Limited
1, Nirlon Complex, Off W. E Highway,
Goregaon East
MUMBAI,Maharashtra,India 400063
Telephone:
22-91-30818000

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