05 Sep
|
Parexel
|
Quebec City
05 Sep
Parexel
Quebec City
Parexel has an exciting prospect for a Clinical Operations Manager (Finance)! This is a hybrid role in Canada.Job PurposeThe Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following:Performance and compliance for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.Budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD).This position has significant impact on the delivery of country specific trial commitments and objectives especially during study start-up.Key AccountabilitiesStudy ManagementManages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality and compliance in assigned protocols in country.Oversees Clinical Trial Coordinators as applicable.Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs),
Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and local milestones.Collaborates closely with Headquarters to align country timelines for assigned protocols.Provides support and oversight to local vendors as applicable.Oversees and coordinates local processes, clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.Enters and updates country information in clinical and finance systems.Delivers clinical and financial contracts within fair market value through continual interaction with local clinical teams.Works in partnership internally with Global Clinical Trial Organization (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarters (HQ) functional areas and externally with vendors and sites, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and Regulatory Authorities in submission and approval related interactions.Finance Management (as applicable)Has ownership of country and site budgets including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research-related payments and
📌 Clinical Operations Manager-Fsp (Quebec City)
🏢 Parexel
📍 Quebec City