Job Description

Clinical Operations Manager - Regulatory

This role is accountable for performance and compliance for assigned protocols in Canada, in accordance with Good Clinical Practices as described by the International Conference on Harmonization, country regulations, our company’s policies and procedures, as well as quality standards and internal and external adverse event reporting requirements.

Under the supervision of the Clinical Operations Manager Lead and the Head of Country Operations, the incumbent is responsible for the execution and oversight of national clinical trial submissions and approvals, as well as site preparation.

What you will do:

Implement and oversee clinical trial submissions and protocol approvals across the country.
Develop local language resources, including informed consents and local language translations. Interact with the Institutional Review Board/Research Ethics Board and the regulatory authority for assigned protocols.
Manage country-level deliverables, timelines, and results for assigned protocols to ensure country commitments are met. Ensure quality and compliance within assigned protocols in the country.
Contribute to the development of local Standard Operating Procedures. Supervise Clinical Trial Coordinators, as applicable.
Coordinate and liaise with the Clinical Research Manager, Clinical Trial Coordinator, Clinical Research Associate (and Finance and Legal departments, where applicable) to ensure country deliverables are met for submissions, budgets, clinical trial agreements, and local milestones. Work closely with headquarters to align country-level timelines for assigned protocols.
Support and oversee local vendors, as applicable.
Oversee and coordinate local processes, management of clinical and related supplies, import and export requirements, supply destruction, local paper/electronic document filing, archiving and document retention requirements, and insurance process management. Enter and update country-specific information in clinical systems.
Assume responsibility for local regulatory compliance. The incumbent has a significant influence on how a country can meet its specific commitments and achieve its trial objectives, particularly during the start-up phase.
Directly or indirectly influence investigators, external partners, and country-level operations.
Partner internally with Global Clinical Trial Operations in the country, Finance, Regulatory Affairs, Pharmacovigilance, Legal, Regional Operations, and headquarters functional areas, as well as externally with vendors, site staff, institutional ethics boards, research ethics committees, and regulatory authorities during submission and approval interactions.
Lead or contribute to initiatives and projects that add value to operations, as needed.
Contribute significantly to enhancing the knowledge of the Clinical Operations Manager, their team, and other roles in the country operations field by acting as a subject matter expert for processes, sharing best practices, making recommendations for continuous improvement, and providing training as needed.
Contribute to enhancing the knowledge of the Clinical Operations Manager’s team by acting as a partner/mentor and sharing best practices as needed.

Key Skills:

Expertise in core clinical systems, tools, and metrics.
Excellent influencing and training/mentoring skills, in both French and English, both orally and in writing.
Excellent coordination and organizational skills.
In-depth knowledge of the local regulatory environment and submission and approval processes; understanding of the impact of these elements on study start-up.
Ability to indirectly influence investigators, vendors, external partners, and country leads to address and resolve issues, with minimal support from their supervisor or the Senior Clinical Operations Manager.
Ability to make decisions independently with limited supervision from their supervisor or the Senior Clinical Operations Manager.
Solid understanding of the 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.

Expected Behavioral Competencies:

Problem-solving is an essential aspect of this position. The incumbent must be able to proactively identify issues and risks, analyze root causes, propose solutions to problems, and escalate them when necessary. Examples of common problems include:

Quality and compliance issues.
Regulatory and legal issues.
Issues related to functional area deliverables that could jeopardize protocol milestones.
Effective time management, organizational and interpersonal skills, and aptitude for problem-solving and conflict management.
Strong sense of responsibility and urgency for prioritizing deliverables.
Strong communication, leadership, and negotiation skills, as well as excellent influencing, training, and mentoring skills, both written and oral, in French and English. Proficiency in English is required to communicate with clinical research stakeholders at the global level, as well as the Ethics Office.
Ability to focus on multiple deliverables and protocols simultaneously is essential. Ability to work effectively in a remote virtual environment with a large number of people.
Positive attitude, growth mindset, ability to work independently.
Ability to directly influence site staff.

Experience and Education:

Five years of experience in clinical research.
Experience with informed consent and negotiation with Research Ethics Boards.
Bachelor's degree in life sciences.

This job posting is for an existing vacancy.

The anticipated base salary range for this position is $110,800 – $160,800 CAD. At our company, we are firmly committed to providing fair compensation for comparable work and experience, which is a fundamental element of our organizational culture. Individual employee compensation is determined based on several factors, including relevant experience, skills and proficiency level, as well as other legitimate factors related to appropriate internal comparators.

At our company, we put people at the heart of our priorities. This position is eligible for our discretionary short-term incentive program, which fosters a pay-for-performance culture. Furthermore, our total rewards and benefits programs go beyond traditional plans (medical and retirement) to create a flexible and inclusive work environment that promotes employee well-being, development, and long-term success.

We may use artificial intelligence and automated tools to support our recruitment process. These tools are used to support, not replace, human judgment. All hiring decisions are made by our hiring managers.

We are proud to be a company that values the contribution of diverse, talented, and committed individuals. The fastest way to foster innovation is to bring together diverse ideas in an inclusive environment. We encourage our colleagues to respectfully challenge each other's perspectives and solve problems collectively. We are an equal opportunity employer and are committed to fostering an inclusive and diverse workplace.

We encourage applications from all qualified individuals. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodations throughout the recruitment process.

Required Skills:

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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Clinical Operations Manager Regulatory

(1 position)

This role is accountable 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.

What you will do:

Execute and oversee clinical trial country submissions and approvals for assigned protocols.
Develop local language materials including local language Informed Consents and translations. Interacts 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. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Influence investigators, external partners and country operations.
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.
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.

You are the ideal candidate if you have:

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

Behavioural Competency Expectations:

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. Specific examples of common problems include:
Quality and compliance issues
Regulatory and legal issues,
Issues related to functional area deliverables that could jeopardize protocol milestones.
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

Experience and Education:

5 years of experience in clinical research
Informed Consent and IRB/IEC Negotiation experience
Bachelor's degree in life sciences

This job posting is for an existing vacancy position.

The anticipated base salary range for this position is $110,800 – $160,800 CAD. At our company, we are firmly committed to provide fair and equitable pay for similar work and experience as a fundamental aspect of our workplace culture. Individual employee salaries will be based on several factors such as relevant experience, skills & proficiency, and/or other bona fide factors relative to appropriate internal comparators.

At our Company, we lead with people. This role includes eligibility to our discretionary short-term-incentive plan which fosters a pay-for-performance culture. Also, our contemporary rewards and benefit programs go beyond traditional medical plans and retirement programs, to create a flexible, inclusive workplace to support employee well-being, development and long-term success.

We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/20/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Clinical Operations Manager

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