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
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
• In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process. Trip report review experience in India and prefer in other AP countries also.