• Clinical Research Associate

by

Nefer HR Consulting Pvt Ltd

Posted on 29-May-2013

• Location(s) Bangalore
• Experience7 to 8 Yrs

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Job Description

Functional AreaAllied Health Services, R&D / Product Design

IndustryPersonal Care / Beauty

Responsible for ensuring that all Medical Review cases are processed in line with the SOPs and timelines as per the SLAs.
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and UCB policies.
Review all forms and documents pertaining to a case for errors, missing information, legibility.
Provide guidance to the team members on the expedited cases.
Provide medical input on difficult adverse event cases.
Review and quality control of the serious and expedited cases as well as non serious cases.
Responsible for submitting the final version of the Aggregate Safety Report to the client.
Ensure US drug safety reporting regulations, ICH guidelines, and Client SOPs are applied by the team members to adverse event case reporting
Evaluate team members adverse event case reports for performance improvement.
Adjust to changing regulatory environment.
Identify, support, and implement continuous improvement activities.
Responsible for escalating the issues or tasks outside the normal scope of work.
Ensure effective and efficient resource utilization.
Define or interpret day-to-day business objectives.
Other Responsibilities 
Responsible for the championing of process enhancements to the team, and to senior management, functional and business leaders
Responsible for compliance and quality.
Identifies business development opportunities and communicates them to the Client Account Lead and senior management.
Manages Service Improvement Programmes within the Delivery operation.
Responsible for functional Operations staff and for maintaining headcount to the agreed plan.
Recognised as having expert knowledge and vision in Client Delivery Operation.
Ensures team attrition is at acceptable targets

Desired Profile:


MBBS Graduates is Mandatory
2 yrs in to clinical research + 2yrs in physician/Practice mandatory
Basic knowledge of Pharmacovigilence is must .