Opportunity to work as Clinical Research Associate ( Executive ) - Vaccines in Panacea Biotec | M.Sc, M.Pharm

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Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Post: Clinical Research Associate ( Executive ) - Vaccines

Job Description

  • To develop Clinical Trial for Vaccines/BA - BE related documents  
  • To assist project manager in site selection and training site personnel
  • To assist in required regulatory submissions & approvals for the conduct of the study
  • To conduct site initiation visits as needed for training site personnel about the protocol and study procedures
  • Provide feedback to assigned sites and information regarding detected deficiencies and corrective action needed.
  • Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
  • Conduct site close out visits to ensure accuracy and completeness of trial related documents and closing of the trial at the site. To keep a close association with site personnel for: patient Recruitment and patient follow-up
  • Preparation and Maintenance of Clinical Trial Master File
  • Resolving all trial related queries, raised from Clinical data management
  • Assisting project manager/managers/ sr. manager to respond to all QA/ Audit findings and coordinating with study sites and vendors for corrective action plans
  • Provide overall management of clinical trials or clinical programs
  • Ensure the project is completed within budget, schedule and according to contract specifications
  • Assisting Managers to arrange literatures and references for articles/publications/presentations
  • To ensure that data is provided to data management for preparation of validation guidelines for a clinical study, data entry and queries resolution
  • To prepare Standard Operating Procedures

Additional Information:
1-4 yrs

Location: Delhi
Qualification: M.Sc, M.Pharm
Functional Area: CR
Last Date:
20th May 2014

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