Responsable local(e) des essais cliniques (dédié(e) au promoteur)

IQVIA•Ottawa, ON

1d•CA$93,000 - CA$124,000•Remote

About The Position

The Local Trial Manager (Sponsor Dedicated) plays a critical role in the delivery of clinical trials by providing country-level oversight of study activities from study start-up through database lock and closeout. This role is responsible for ensuring the delivery of high-quality data, adherence to timelines and budgets, and compliance with study protocols, Standard Operating Procedures (SOPs), International Council for Harmonisation Good Clinical Practice (ICH-GCP), and applicable regulatory requirements. Operating in a fast-paced environment with evolving priorities, the Local Trial Manager works closely with clinical teams, study sites, vendors, and internal stakeholders to ensure successful trial execution and contribute to improving patient outcomes through the advancement of innovative therapies. Successful candidates will possess strong clinical trial management experience, including expertise in site selection, patient recruitment strategies, informed consent management, monitoring visit report review, and the implementation of risk mitigation plans to proactively address study challenges.

Requirements

Bachelor's degree in Life Sciences, Health Sciences, or a related field.
Minimum of two years of clinical trial management experience in a role accountable for driving and overseeing local clinical trial activities at the country or regional level.
Strong knowledge of ICH-GCP, clinical trial protocols, SOPs, and applicable regulatory requirements.
Strong understanding of site selection, patient recruitment, and informed consent processes.
Excellent project management, organizational, planning, and prioritization skills.
Demonstrated ability to identify, assess, and manage study-related risks and issues.
Strong written and verbal communication and presentation skills.
Excellent problem-solving and decision-making abilities.
Ability to manage competing priorities in a fast-paced environment.
High attention to detail and a quality-focused, results-driven approach.
Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint, as well as clinical trial management systems.
Ability to build and maintain effective working relationships with colleagues, managers, clients, investigators, site personnel, and vendors.
Ability to work effectively across multiple functions and geographic regions.
Good understanding of study budgets, forecasting, and financial processes related to clinical trial management.
Fluency in English is required.
Must reside in the same country where the job is located.

Nice To Haves

Additional clinical trial management experience is considered an asset.
French language proficiency is considered a strong asset.

Responsibilities

Contribute to the development and implementation of integrated study management plans in collaboration with global and local study teams.
Provide operational oversight of assigned protocols at the country level from study start-up through closeout.
Participate in feasibility assessments and site selection activities to ensure the identification of high-quality research sites.
Collaborate with central study teams and local stakeholders to support final site selection decisions.
Ensure recruitment targets are achieved through the delivery of high-quality data, within established timelines and study budgets.
Develop and coordinate country-level recruitment, risk management, and contingency plans as required.
Serve as the primary company contact for assigned trials at the country level.
Attend and participate in Investigator Meetings and conduct local investigator meetings as needed.
Monitor study progress using trial management systems and study reports.
Implement corrective and preventive actions (CAPAs) when study activities deviate from established plans.
Communicate study progress, risks, and issues proactively to study management and quality teams.
Collaborate with cross-functional teams to support milestone achievement and the resolution of study-related challenges.
Support site-level patient recruitment strategies and contingency planning initiatives.
Manage country-level vendors, including vendor selection, oversight, and invoice approval as required.
Support local study supply management where applicable.
Maintain high standards of study quality and support training of local study team members when necessary.
Prepare and manage country-specific informed consent documentation in accordance with applicable procedures and regulations.
Ensure adverse events (AEs), serious adverse events (SAEs), and other safety-related information are reported within required timelines.
Maintain inspection readiness through accurate and timely management of essential study records and documentation.
Partner with clinical monitoring teams to ensure implementation of CAPAs resulting from audits, inspections, or quality reviews.
Support study budget management, forecasting, and financial oversight activities.
Assist with site contract and budget negotiations where applicable.
Ensure compliance with local regulatory requirements and support submission and approval activities with regulatory authorities and ethics committees.
Contribute to continuous improvement initiatives, training activities, and process optimization efforts.