Covance FSP - Clinical Operations Manager – Regulatory in Montreal, Canada
The COM is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally
FINANCIAL: Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD.
MANAGEMENT & QUALITY OVERSIGHT: Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to the development of local SOPs. May oversee contract workers (CTCs) and local vendors as applicable.
COLLABORATION: Works in close collaboration internally with GCTO country operations (CRM, CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
LOCAL PROCESS OVERSIGHT: Oversight and coordination of local processes. Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical, regulatory, safety and finance systems. Problem solving and Process Improvement is essential to this position. Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable.Specific examples of common problems include:1) Issues in budget / CTRA negotiations2) Quality and compliance issues3) Regulatory and legalissues4) Issues related to functional area deliverables that could jeopardize protocolmilestones.
Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science orequivalent Health Care related experience
5-7 years clinical research experience
Extensive experience in clinical project management and coordination.
Expertise of core clinical, regulatory and financial systems, tools and metrics
Extensive knowledge of local regulatory environment and submission and approvalprocesses.
Additionally for financial responsibilities: Background in business finance is preferred andstrong knowledge and aptitude in accounting and financial procedures.
Job Number 2018-24307
Job Category Hidden (23502)
Position Type Full-Time
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