Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world. Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.
Post : Sr CRA Trip Report Reviewer
Responsibilities:
• Ensure accurate and timely trip report completion and trip report review and the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate
• Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues
• Ensure site monitoring responsibility for clinical studies are conducted according to Covance
• Standard Operating Procedures, ICH Guidelines and GCP
• Ensure follow up on action items and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues
• Responsible for the timely and appropriate communication to the clinical operations team
• Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
• Assures the implementation of project plans as assigned
• Assist with training, mentoring, and development of new employees
• Review progress of project and initiate appropriate actions to achieve target objectives
• Contribute to improvements to enhance the efficiency and quality of work on assigned projects
Candidate Profile
Graduate in any discipline preferable lifesciences.
8+ years of experience into Trip report reviewing.
Additional Information:
Experience : 8+ years
Qualification : Graduate
Industry Type: Pharma
Functional Area: CRA
Job Number : 2018-19613
End Date : 5th June, 2018
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