Sr Mgr, Clinical Trial Mgmnt, Taipei

"At ICON, it's our People that set us Apart"

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 12,600 employees. Further information is available atwww.iconplc.com

Sr Mgr. Clinical Trial Management

Job Description;

• *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.
• Actively identify 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 . May act as the primary point of contact for smaller or single service projects.
• *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 reports (MVR) and Follow up Letters (FUL) timelines , Action Items (Al) 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 or take the role of a Global CTM.
• *Responsible for co-ordinating , managing and mentoring the clinical project team to ensure • high performance and productivity (e.g . Days on Site for CRAs) • optimal utilization, • continuous development • minimal turnover A Symbol of Excellence • all necessary project training is provided, documented and filed appropriately . •
• *Active involvement in clinical risk planning and assessment , developing mitigation strategies and associated action plans, 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 deliverab les. •
• *Implement QC activities , ensure compliance with quality measures , and monitor required quality metrics. •
• Develop a succession plan for clinical study team members and, in the event of a change to the team, ensure an effective hand-over that is appropriately documented . •
• Participate in the hiring interview process, if applicable. •
• *Maintain confidentiality of information , as appropriate . •
• Participate in business development activities including bid defense meetings; may be required to provide input to the clinical strategy . •
• May be required to undertake specific PM tasks, as agreed with Line Manager HR006-SOP-F01Nersion 1 O/ Effective: 10 February 2015 (Ref HR006-SOP) Page 3 of 5 •
• Participate in Company/Departmental initiatives , as requested . •
• Undertake other reasonably related duties as assigned . A Symbol of Excellence

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