Clinical Operations Manager

2 weeks ago

Montréal QC, Canada Parexel Full time

Parexel FSP is looking for a Clinical Operations Manager- FINANCE. The 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).
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
• 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 payment
reconciliation at study close-out
• Oversees Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems and financial forecasting in conjunction with Senior Clinical Operations Manager, Clinical Research Director and other roles
• Regulatory Management (as applicable)
• Executes and oversees clinical trial country submissions and approvals for
Develops local language materials including local language Informed
Interacts with IRB/ IEC and Regulatory Authority for assigned protocols

Contributes or leads initiatives and projects adding value to the business.
• Contributes strongly to the Clinical Operations Manager team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
• Compliance with Parexel standards
• Complies with required training curriculum
• Skilled knowledge of budget and contract negotiations, local regulatory environment
and submission and approval processes, and understanding of how these impact study start-up
• Requires a strong understanding of local regulatory environment
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally
• Requires ability to proactively identify issues and risks,
analyze root cause and propose solutions and escalate to management as applicable.
o Quality and compliances issues
o Regulatory and legal issues
Effective and efficient time management, organizational and interpersonal
skills, and conflict management skills
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills
• Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people
• Ability to directly influence site staff
• Excellent verbal and written influencing and training/mentoring skills, in local language and
English
• 5-7 years clinical research or combined experience in Clinical Research and Finance/Business • Expertise of core clinical, regulatory, and financial systems, tools, and metrics

Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent
Health Care related experience

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