Chef, opérations cliniques / Clinical Operations Manager

MSD•Kirkland, QC

7d•CA$110,800 - CA$160,800•Remote

About The Position

The incumbent is responsible for performance and compliance for assigned protocols in Canada in compliance with Good Clinical Practices as described by the International Conference on Harmonization and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Clinical Operation Manager Lead, and Head of Country Operations, the person is accountable for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. This role has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. The incumbent will work in partnership internally with Global Clinical Trial Operations country operations, Finance, Regulatory Affairs, Pharmacovigilance, Legal and Regional operations, Head Quarter’s functional areas, as well as externally with vendors and sites, Institutional Review Boards, Institutional Ethics Committees, and Regulatory Authorities in submission and approval related interactions. The role also contributes strongly to the Clinical Operations Manager’s team and other Country Operations roles knowledge by acting as process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. The incumbent will also act as a buddy/mentor to the Clinical Operations Manager team and share best practices.

Requirements

Expertise of core clinical systems, tools and metrics
Excellent verbal and written influencing and training/mentoring skills, in French and English
Strong coordination and organizational skills
Skilled knowledge of local regulatory environment and submission and approval processes and understanding of how these impact study start-ups.
Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Senior Clinical Operation Manager or Clinical Operation Manager Lead.
Ability to make decisions independently with limited oversight from Senior Clinical Operation Manager or Clinical Operation Manager Lead.
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 Clinical Trial Coordinators as applicable
Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
High sense of accountability and urgency in order to properly prioritize deliverables
Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in French and English.
Ability to focus on multiple deliverables and protocols simultaneously is essential.
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 being self-driven
Able to directly influence site staff
5 years of experience in clinical research
Informed Consent and IRB/IEC Negotiation experience
Bachelor's degree in life sciences

Nice To Haves

Adaptability
Clinical Risk Management
Clinical Site Management
Clinical Trial Agreements (CTA)
Clinical Trial Compliance
Clinical Trial Planning
Clinical Trials Logistics
Clinical Trials Monitoring
Clinical Trials Operations
Clinical Workflows
Cross-Cultural Awareness
Healthcare Operations
ICH GCP Guidelines
Problem Solving
Regulatory Compliance
Study Start Up

Responsibilities

Execute and oversee clinical trial country submissions and approvals for assigned protocols.
Develop local language materials including local language Informed Consents and translations.
Interact with Institutional Review Board /Institutional Ethics Committee and Regulatory Authority for assigned protocols.
Manage country deliverables, timelines and results for assigned protocols to meet country commitments.
Responsible for quality and compliance in assigned protocols in country.
Contribute to the development of local Standard Operation Procedures.
Oversees Clinical Trial Coordinators as applicable.
Coordinate and liaise with Clinical Research Manager, Clinical Trial Coordinator, Clinical Research Associate, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements and local milestones.
Partner closely with Headquarter to align country timelines for assigned protocols.
Provide assistance and oversight to local vendors as applicable.
Oversee and coordinates local processes, 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 systems.
Ownership of local regulatory compliance.
Influence investigators, external partners and country operations.
Contribute or leads initiatives and projects adding value to the business, as appropriate/required.
Contribute strongly to the Clinical Operations Manager’s team and other Country Operations roles knowledge by acting as process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Contribute to the Clinical Operations Manager team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.