Job Opening For Clinical Research Associate in Mumbai- PPD Pharmaceutical Development IndiaMarch 21st, 2011 Posted by VFreshers
Pharma Graduates Clinical Research Job Opportunities in PPD Pharmaceutical Development India Mumbai- 21 March 2011
Job Position : Clinical Research Associate
No of Opening : 1
Name of the Company : PPD Pharmaceutical Development India Pvt Ltd
Experience: 1 – 3 Years
Job Location: Mumbai
Rupees 2,50,000 – 4,50,000
Qualification : B.Pharma – Pharmacy
Job Responsibilities :
- Performs and coordinates Identification and selection of qualified study sites, site evaluation visits in accordance with ICH GCP and FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites.
- Works in conjunction with the Clinical Submissions Specialist(s) and Clinical Contracts Specialist(s) to prepare investigational sites for initiation.
- Represents PPD in the global medical research community and develops collaborative relationships with investigational sites.
- Supports local Clinical Management in the mentorship, training and work direction of local start-up team members.
- Identifies and suggests potential process improvements.
- Provides feedback on tools, processes and procedures.
- Acts as a point of reference for operational and role-specific questions. May assist management team with certain project management functions.
- Identify potential investigators in collaboration with the Sponsor, Project Manager, Clinical Team Manager and Clinical Management, as appropriate.
- Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites.
- As necessary, support the Clinical Submission Specialist(s) with the preparation and submission of regulatory, ethics committee and provincial applications and regulatory packages.
- As necessary, support the Clinical Submissions Specialist(s) to ensure the proper essential documents are in place prior to trial start-up; to assist in the preparation of Regulatory Compliance Review packages.
- Facilitate, in conjunction with the Clinical Contracts Specialist(s) the administrative set-up of sites, laboratories, storage facilities, equipment, etc.
About Company :
PPD is a leading global contract research organization, celebrating 25 years of providing discovery and development services and drug lifecycle management. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 41 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe, effective therapeutics to patients and maximize returns on their R&D investments.
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