Chef, opérations cliniques / Clinical Operations Manager

Merck•Kirkland, QC

7d•CA$110,800 - CA$160,800•Remote

About The Position

The Clinical Operations Manager is responsible for the execution and compliance for assigned protocols in Canada, in compliance with Good Clinical Practices (GCP) as developed by the International Conference on Harmonisation (ICH) 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 role is responsible for the 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 position influences investigators, external partners, and country operations. The role works in partnership internally with Global Clinical Trial Operations country operations, Finance, Regulatory Affairs, Pharmacovigilance, Legal, Regional operations, and Head Quarter’s functional areas, as well as externally with vendors, sites, Institutional Review Boards, Institutional Ethics Committees, and Regulatory Authorities in submission and approval related interactions. The role may lead or contribute to initiatives and projects that add value to the business. The Clinical Operations Manager contributes strongly to the knowledge of the Clinical Operations Manager’s team and other Country Operations roles by acting as a process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement, and providing training as needed. The role also contributes to the Clinical Operations Manager team knowledge by acting as a buddy/mentor and sharing best practices as needed.

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

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.
Ensure quality and compliance in assigned protocols in country.
Contribute to the development of local Standard Operation Procedures.
Oversee 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 coordinate 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.
Enter and update country information in clinical systems.
Take ownership of local regulatory compliance.
Influence investigators, external partners and country operations.
Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
Act as a process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Act as a buddy/mentor and sharing best practices as appropriate/required.