Clinical Operations Manager-Fsp (Quebec City)

Clinical Operations Manager-Fsp (Quebec City)

06 Aug
|
Parexel International
|
Quebec City

06 Aug

Parexel International

Quebec City

Parexel has an exciting opportunity for a Clinical Operations Manager (Finance)! This is a hybrid role in Canada. Job Purpose Performance and compliance for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Positive 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 Accountabilities Study Management Manages 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 Headquarter 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, Headquarter (HQ) functional areas and externally with vendors and sites, Internal 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 International
📍 Quebec City

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: clinical operations manager-fsp (quebec city) / quebec city

Subscribe to this job alert:

Get the latest job offers by email for: clinical operations manager-fsp (quebec city) / quebec city