Country Study Manager - Hiring Urgently

We are on the lookout for a confident Country Study Manager to join our passionate team at ICON in Teletrabajo.
Growing your career as a Full Time Country Study Manager is an incredible opportunity to develop excellent skills.
If you are strong in teamwork, planning and have the right initiative for the job, then apply for the position of Country Study Manager at ICON today!

As Country Study Manager (CSM), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. 

 

You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks.

 

You will be part of an innovative and global Biotechnology company, who pride themselves to be one of the world's leading independent biotechnology companies. They focus on areas with unmet medical need with the ambition to help reduce the social and economic burden of disease in society today.

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.

What you need: 

• Bachelor’s degree in a health, life sciences, or other relevant field of study. 
• Minimum 5-6 years’ work experience in clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Minimum 2-3 years’ experience of leading local/regional or global teams and Clinical trial project management
• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

* Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.

 

Why ICON:

 

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with varied skills, perspectives & backgrounds working together across 40 countries.  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. At 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. 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, color, 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 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 role.

Benefits of working as a Country Study Manager in Teletrabajo:

● Learning opportunities
● Company offers career progression opportunities
● Competitive salary