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Senior Clinical Research Associate

9.00 to 12.00 Years   Delhi   23 Nov, 2021
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

Designation: Sr. CRAJob Location: BangaloreDepartment: Clinical OperationsAbout SyngeneSyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.Job Purpose: Perform site selection, initiation monitoring and close-out visits in accordance with contracted scope of work, Standard Operating Procedures and all the applicable Good Clinical Practice (GCP) Guidelines and Regulations. Responsible for site management for the assigned protocols, sites and therapeutic areas Complete appropriate Standard Operating procedure trainingKey Responsibilities:

    1. Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work, Standard Operating Procedures and all the applicable Good Clinical Practice (GCP) Guidelines and Regulations.
    2. Responsible for site management for the assigned protocols, sites and therapeutic areas
    3. Complete appropriate Standard Operating procedure training, therapeutic area training, protocol training and any relevant training required to perform job duties
    4. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectation and activities
    5. Ensure the quality and integrity of study conducted at site level in accordance with protocol and applicable regulations. Investigate and discuss quality issues with Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action
    6. Manage the progress and performance of the assigned study sites by following activities but not limited to: tracking regulatory and Ethics Committee submissions and approvals, subject recruitment, case report form (CRF) completion and submission, and data query generation and resolution.
    7. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentations.
    8. Provide assistance to the Clinical Project Manager with design of study tools, documents and processes.
    9. Timely submission of timesheets for Project specific and other tasks
    10. Assignment as a Lead Clinical Research Associate (if required), the responsibilities could include:
    11. Supporting the Clinical Project Manager for coordination with-in the project team.
    12. Delegation of project level Clinical Project Manager responsibilities
    13. The above responsibilities would be assigned by reporting manager and project-level task allocation would be performed.
Educational Qualification:B. Pharm/M. Pharm/BAMSTechnical/functional Skills:
  • Regulatory knowledge
  • Monitoring skills
  • operational skills
  • Job knowledge and needs to work according to the requirement
Experience:9-12 years,

Keyskills :
project managementgcpmentoringadministrationbusiness developmentgood clinical practiceequal employment opportunitystandard operating procedures

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