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Clinical Trial Manager

  1. Colombia
2024-110309
  1. ICON Strategic Solutions
  2. Clinical Trial Management
  3. Office Based

About the role

This vacancy has now expired. Please see similar roles below...

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

 

You will be partnering with one of our  global pharmaceutical clients; a company that  is advancing the development of new medicines, biologic therapies and vaccines for many of  the  world’s  most  challenging diseases  including  cancer,  cardio-metabolic diseases, Alzheimer’s  and  infectious  diseases.  Be  ready  to   work   in  a   solid  partnership and  an environment driven by innovation and continuous improvement.


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).
  • Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
  • 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.
  • 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).
  • 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 and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
  • Identifies and facilitates resolution of cross-functional study-specific issues.
  • Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
  • Executes regulatory agency inspection readiness activities (e.g., TMF review, story board generation).
  • Collaborates with local teams to ensure country level study delivery is aligned with global expectations.
  • Identifies risk, implementing risk mitigation strategies, and resolving issues at a country/site level, as well as informing the CST / TMT, LST and local teams of risks associated with delivery in a proactivetimely and solution orientated manner.

You are:

  • Bachelor’s degree in a health, life sciences, or other relevant field of study. 
  • Minimum 5 years’ work experience in clinical research or experience 
  • Regulatory knowledge required
  • Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)


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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