Clinical Operations Manager - Regulatory

Parexel; Montreal , Kirkland; Híbrido; CAD 85 000 - 120 000; Tempo integral

Resumo da oferta

Parexel is seeking a Clinical Operations Manager Regulatory (COM-R) in Montreal. The role focuses on country submissions, regulatory compliance, and budget oversight. Travel to the Merck office in Montreal/Kirkland is required two days per week.

The position involves coordinating with Clinical Research Managers, Finance, Legal, and HQ to ensure country milestones and study start-up success. Strong leadership and risk management are essential.

Qualificações

• Bilingual (French and English) required.
• Ability to travel to Montreal Merck office 2 days per week.
• Strong coordination and organizational skills are essential.

Responsabilidades

• Execute and oversee country submissions and approvals for assigned protocols.
• Develop local language materials including informed consent forms and translations.
• Collaborate with GCTO, finance, regulatory affairs, legal and HQ to align country timelines and deliverables.
• Supervise Clinical Trial Coordinators as applicable.
• Provide oversight to local vendors and manage country processes, import/export, filing and archiving.

Conhecimentos

Budget negotiations

Contract negotiations

Local regulatory env.

Submission & approvals

Team leadership

Risk management

Descrição da oferta de emprego

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring multiple Clinical Operations Managers Regulatory in Montreal, Kirkland.

Candidates must be bilingual (French and English) and must be able to go to the Merck office in Montreal, Kirkland, 2 days per week .

The 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.

Supporting Activities

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

Regulatory Management

• Executes and oversees clinical trial country submissions and approvals for assigned protocols
• Develops local language materials including local language Informed Consents and translations - Interacts with IRB/ IEC and Regulatory Authority for assigned protocols

Team development and support

• 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.
• Contributes to Clinical Operations Manager team knowledge by acting as a buddy/mentor and sharing best practices as appropriate/required.

Skills

• Strong coordination and organizational skills.
• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
• Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager
• Ability to make decisions independently with limited oversight from SCOM or manager.
• Requires a strong understanding of local regulatory environment.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally
• Ability to lead a team of CTCs as applicable
• Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escal to management as applicable. Examples include: o Issues in budget/CTRA negotiation o Quality and compliances issues o Regulatory and legal issues o Issues related to functional area deliverables that could jeopardi