responsable clinique / Clinical Lead
$124,400–$207,300 year
On-siteKirkland, Quebec, Canada
Job Summary
Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer contracts, and internal SOPs. Account for meeting recruitment targets and developing appropriate strategies. Contribute to the project risk mitigation plan and manage clinical risks throughout the project lifecycle. Ensure clinical quality delivery by identifying standards, planning compliance measurement, and overseeing issue management. Manage clinical aspects of project finances, including the Estimate at Completion (EAC), and monitor changes to identify additional service opportunities. Identify and manage internal and external stakeholders through effective communication and resolution. Collaborate with the clinical team to support milestone achievements and report to stakeholders as required. Resource and plan the clinical team, establishing high-quality operational plans and guidance. Conduct regular team meetings, support professional development by providing performance feedback, and mentor new peers. May contribute to clinical delivery strategy for proposals, participate in bid defenses, and present clinical operation plans. May work alongside other leads to deliver large, global trials and attend site visits as applicable.
Required Qualifications
- Bachelor's Degree in health care or other scientific discipline
- 5 years clinical research/monitoring experience or equivalent combination of education, training and experience
- Basic knowledge of Project management practices and terminology
- Good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Broad protocol knowledge and therapeutic knowledge
- Good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
- Understanding of project finances
- Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines
- Strong written and verbal communication skills including good command of English language
- Problem solving skills
- Planning, time management and prioritization skills
- Ability to handle conflicting priorities
- Attention to detail and accuracy in work
- Good influencing and negotiation skills
- Good judgment and decision-making skills
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
- Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Ability to work across geographies displaying high awareness and understanding of cultural differences
- Ability to influence without authority
- Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership)
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