ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career.
Post : Clinical Trial Manager
• To effectively manage the activities of individual studies in a manner that ensures all timeframes and targets are met and that costs are kept under control.
• Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
• As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs.
• Participate in opportunities for process improvement.
• Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.
• Travel (approximately 25%) domestic and/or international.
• Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.
• Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments;
• Protocol deviation prevention, tracking and reporting; IP management, timely investigator payments.
• Responsible for driving enrolment as per contracted timelines.
• Regular oversight of key clinical metrics including but not limited to: Days on Site (DOS), Monitoring Visit Report (MVR) and Follow up Letters (FUL) timelines, Action Items (AI) and other quality metrics, to ensure they are met and followed-up as necessary.
• Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with the Central Visit Report Approvers, as appropriate.
• Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner.
• Contribute to the development and maintenance of all clinical elements of cross functional project plans.
• Able to work on multinational studies and may take the role of a Global CTM if appropriate.
• Responsible for coordinating and managing the clinical project team to ensure: o high performance and productivity (e.g. DOS for CRAs) o optimal utilization o minimal turnover o all necessary project training is provided, documented and filed appropriately.
• Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including issue escalation and resolution.
• Responsible for the development and maintenance of operational plans for clinical deliverables e.g. CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc.
• Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary.
• This includes documented QC checks of in house investigator site files.
• Ensure all close-out activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved.
• Lead and/or actively participate in the conduct of clinical team meetings.
• Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables.
• Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.
• Maintain confidentiality of information, as appropriate.
• Participate in business development activities such as bid defense meetings
• May be required to undertake individual, finite PM tasks under supervision and with support of the Line Manager.
• Participate in Company/Departmental initiatives, as requested.
• Undertake other reasonably related duties as assigned.
Minimum educational degree requirements: Bachelor’s degree in Life science
Qualification : Bachelor’s degree in Life science
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Trial
End Date : 30th December, 2018
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