Country Clinical Research Lead (Bilingual French/English) - Montreal, Quebec

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Country Clinical Research Lead (CRL) responsibilities include operational delivery of strategic clinical studies assigned to the country, to support Incyte’s pipeline, in accordance with ICH/GCP, Incyte SOPs, local operating guidelines and local requirements, as applicable.

The CRL works locally, supporting Associate Director Clinical Operations (ADCO) / Director Clinical Operations (DCO), to ensure corporate/country goals for recruitment and completion of key R&D sponsor deliverables are met.

What you will be doing:

• Support ADCO / DCO to:
  • Oversee local CRO activities, acting as Single Point of Contact for key and strategic outsourced clinical studies,  to  ensure  corporate  and  country  objectives  are  reached  and  potential  country  issues properly followed-up.
  • Collaborate and liaise with Clinical Study Teams and Global Monitoring, for in-house clinical studies conducted within country/ies ensuring key project milestones and high quality are delivered.
  • Partner with local Study Startup Specialist (SSS) or Clinical Research Associates (CRAs) to ensure consistency and accuracy of all core documents for local EC submission, as applicable, for in-house clinical studies (i.e. submission pack, document customization, translations, quality check).
•  Support Feasibility process to:
  •  Act  as  the  central  point  of  contact  for  feasibilities  in  the  country/ies,  for  both  in-house  and outsourced clinical studies when feasibilities are requested or deferred to country/ies by Global Teams
  • Carry out top Level feasibilities, to collect key information on competitive clinical studies, marketed and non-marketed drugs, regulatory concerns, Standard of care, etc…
• Build up professional relationship with the investigators and Key Opinion Leaders.
• Liaise with Country, ADCO/DCA and EU CRA Manager for CRAs assignment
• Once trained, support the  Global Monitoring team to conduct co-monitoring and CRA assessment visits, when needed and requested
• Supports ADCO / DCO to prepare internal initiatives, meetings and trainings (as required)
• Support the ADCO / DCO to implement local SOPs / WIs, quality/compliance review and initiatives, to ensure inspection readiness
• Act as a Site Relationship Partner for specific studies, to build and retain relationships through the lifecycle of the clinical study, to ensure an effective clinical study conduction and completion
• Act in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
• Collaborates with Medical Affairs Department, as well as all country internal stakeholders
• Collaborates and interact with QA, Global Monitoring, clinical Study Start-Up teams, Global Clinical Trial
• Managers (CTMs), Global Regulatory and other as work needs

You must have:

• At least 5 years clinical research experience as CRA or Lead CRA or Project Manager
• Bachelor or higher University degree in life sciences, nursing or medical background preferred
• Must be Bilingual - French and English 
• Must reside in Montreal, Quebec
• Demonstrated knowledge of clinical trial methodology and drug development process, related to monitoring clinical trials, GCP, SOP and country-specific regulatory requirements.
• Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology
• Demonstrated attitude to team work and cross-functional collaboration
• Ability to establish and maintain effective working relationships with co-workers, managers, internal and external stakeholders
• Effective oral, written and presentation skills, with the ability to communicate effectively with varied audiences
• Demonstrated professionalism and presentation of a positive image of the company
• Strong attitude to problem solving, effectively prioritize tasks and  working independently
• Effective organizational and time management skills
• Proven flexibility and adaptability
• Available for domestic and international travel, including overnight stays up to approximately 20% of the working week

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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 or submit a request here.

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.