Local clinical trial manager (dedicated to the sponsor)

Local clinical trial manager (dedicated to the sponsor) at Lifelancer in United States.

Role Summary

• Job Title: Local clinical trial manager (dedicated to the sponsor)
• Job Location: Ottawa, Ontario, Canada
• Job Location Type: Remote
• Job Contract Type: Full-time

Responsibilities

• Contribute to the development and implementation of integrated study management plans in collaboration with the central project team and local teams.
• Ensure operational supervision of protocols assigned at the national level, from study initiation to completion.
• Participate in feasibility and site selection activities to ensure the selection of high-quality research centers.
• Collaborate with central teams and local stakeholders for the final selection of centers participating in the studies.
• Ensure that recruitment objectives are achieved through quality data, produced on time and on budget.
• Develop and coordinate local recruitment, risk management and business continuity plans when required.
• Act as the primary company point of contact for nationally assigned testing.
• Participate in investigator meetings and, if necessary, organize and lead local meetings.
• Monitor study progress using available management systems and reports.
• Implement corrective and preventive measures (CAPA) when activities deviate from established plans.
• Proactively communicate risks, issues and progress of studies to the management teams concerned.
• Collaborate with functional teams to ensure milestones are achieved and study-related issues are resolved.
• Support the development and implementation of patient recruitment strategies and contingency plans.
• Ensure supplier management at the national level, including selection, performance monitoring and approval of invoices when required.
• Support the management of local study supplies where applicable.
• Maintain high standards of quality and support training of local team members on study processes.
• Prepare and manage country-specific informed consent documents in accordance with applicable procedures and regulatory requirements.
• Ensure that adverse events (AEs), serious adverse events (SAEs) and other safety events are reported in accordance with regulatory requirements.
• Ensure a consistent state of inspection readiness through maintaining complete, accurate and up-to-date records in clinical trial management systems and electronic master records.
• Collaborate with clinical surveillance managers to ensure the implementation of CAPAs resulting from audits, inspections or other quality-related activities.
• Participate in the budgetary management of studies, financial forecasts and monitoring of local expenses.
• Contribute, when required, to the negotiation of budgets and contracts for study sites.
• Ensure study compliance with local regulatory requirements and support obtaining necessary approvals from regulatory authorities and ethics committees.
• Participate in continuous improvement, training and process optimization initiatives.
• 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.

Requirements

• Bachelor's degree in life sciences, health sciences or a related field.
• Minimum of two years of experience in clinical trial management in a position with direct responsibility for the management and supervision of local clinical trial activities at the national or regional level.
• Additional experience in clinical study management is an asset.
• Solid knowledge of Good Clinical Practices (ICH-GCP), clinical study protocols, standard operating procedures and applicable regulatory requirements.
• Good understanding of site selection, patient recruitment and informed consent management processes.
• Excellent project management, organizational, planning and priority setting skills.
• Demonstrated ability to identify, assess and manage risks and issues related to clinical studies.
• Excellent oral and written communication and presentation skills.
• Strong problem-solving and decision-making skills.
• Ability to manage competing priorities in a dynamic environment.
• Great attention to detail and an approach focused on quality and results.
• Proficient in Microsoft Office suite software, including Word, Excel and PowerPoint, as well as clinical trial management systems.
• Ability to establish and maintain effective working relationships with colleagues, managers, clients, researchers, site staff and suppliers.
• Ability to work effectively with teams located across geographies and functions.
• Good understanding of study budgets, forecasts and financial processes related to clinical trials.
• Fluency in English is required. Knowledge of French is considered an important asset.
• You will work directly with IQVIA departments, teams, support functions and stakeholders located across Canada and around the world. Therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position. Fluency in French is considered an asset.
• Please submit your resume in English.
• To be eligible for this position, you must reside in the same country where the job is located.

Local Trial Manager (Dedicated Sponsor)

The Local Trial Manager (Dedicated Sponsor) plays a critical role in the delivery of clinical trials by providing country-level oversight of study activities from study start-ups 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 Harmonization 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.
• 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.
• Additional clinical trial management experience is considered an asset.
• 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. French language proficiency is considered a strong asset.

You will be required to work directly with IQVIA departments, teams, support functions, and stakeholders located across Canada and around the world. Therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position. French language proficiency is considered an asset.

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement.

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• Please submit your resume in English.
• To be eligible for this position, you must reside in the same country where the position is located.

Local clinical trial manager (dedicated to the sponsor)

The local clinical trial manager (dedicated to the sponsor) plays an essential role in the delivery of clinical trials by providing oversight of study activities at the national level, from the start-up phase through to database lock and study closure. This person is responsible for ensuring the production of high quality data, adherence to deadlines and budget, as well as compliance with protocols, standard operating procedures (SOP), Good Clinical Practices (ICH-GCP) and applicable regulatory requirements.

In a dynamic environment with constantly evolving priorities, this position collaborates closely with clinical teams, sites, suppliers and internal stakeholders to ensure the efficient execution of clinical studies and contribute to the improvement of patient care by accelerating the development of new therapies.

Candidates who will succeed in this role will have strong experience in clinical trial management, including site selection, patient recruitment strategy, managing the informed consent process, reviewing monitoring visit reports, and implementing risk mitigation plans to proactively address study challenges.