Clinical Operations Manager - Regulatory

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 escalate 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 jeopardize protocol milestones

• Effective and efficient time management, organizational and interpersonal skills, and conflict management skills

• High sense of accountability and urgency to prioritize deliverables

• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills

• Ability to focus on multiple deliverables and protocols simultaneously

• Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people

• Positive mindset, growth mindset, capable of working independently and self – driven.

• Ability to directly influence site staff

• Excellent verbal and written influencing and training/mentoring skills, in local language and English

• Minimal travel required

Knowledge and Experience:

• 5-7 years clinical research or combined experience in Clinical Research and Business

• Expertise of core clinical, regulatory, and financial systems, tools, and metrics

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