Clinical Trial Manager II

As aClinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
• Supports country-level  operational  planning  and accountable  for  site  selection within  assigned country/-ies.
• Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
• Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs)  as applicable, agenda driven, present at meetings.
• Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems.
• Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
• Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
• Provides oversight  and  monitoring  of  applicable  vendor  activities  e.g.,  laboratories  and equipment provisioning.
• Engages with  local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team, DOM)
• Provides country level input into the Country  Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
• Responsible for approval of Baseline and Revised Enrolment Plans (Country Level)
• Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.
• Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
• Translates global start up requirements into local country targets
• Monitors country  enrolment  and  retention  and  act  on  deviations  from  plan.  Identify  barriers  to enrolment and support recruitment and retention strategic solutions.
• Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
• Monitors and reviews country and study trends.
• Reviews Monitoring Visit Reports.
• Identifies and facilitates resolution of cross-functional study-specific issues.
• Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).
• Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
• Escalates CRA performance issues to applicable Clinical Trial Oversight Manager.
• Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of site relationships.

You are:

• Organised, creative and confident in taking independent action.

• To ensure success within this role, the following are required:

• A proven track record within study management
• An ability to combine creativity, leadership and experience to empower a team to succeed
• Prior experience of budget forecasting, feasibility, study start up, on-site monitoring and site management
• Confidence in your decision-making abilities
• A working knowledge of a broad range of therapeutic areas
• Degree in a health or science related discipline
• Fluency in English
  Why ICON?
  
  Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
  
  Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
  
  ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
  
  If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
  
  Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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