Clinical Operations Manager

6 months ago

Montréal, Canada ICON Full time

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

**What you will be doing**:
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

**Responsibilities include, but are not limited to**:

- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles.
- 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.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contributes to the development of local SOPs. Oversees CTCs as applicable.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Provide support and oversight to local vendors as applicable.
- Oversees 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 and finance systems.
- Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
- Required to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
- Contributes strongly to COM 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 COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

**What you need to have**:

- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
- 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 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 mínimal support from the Sr.COM or manager.
- Ability to make decisions independently with limited oversight from Sr.COM or manager.
- Requires 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
- To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status

**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve mad

  • Manager, Clinical Operations

    6 months ago

    Montréal, Canada ICON plc Full time

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: As a Clinical Operations Manager at ICON, you’ll work ensure...

  • Clinical Advisor

    6 months ago

    Montréal, Canada Clinical Research Dental Full time

    **Position Summary** This particular role is for an already established Territory throughout Montreal. Fluent French is required. The **Clinical Advisor** (Dental) is accountable for developing sales and providing education within their assigned territory consistent with strategic and corporate goals and values. The role includes all facets of territory...

  • Clinical Operations Manager

    3 weeks ago

    Montréal, QC, Canada Parexel Full time

    Parexel FSP is looking for a Clinical Operations Manager- FINANCE. The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ 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...

  • Clinical Operations Manager- Finance

    3 weeks ago

    Montréal, QC, Canada Parexel Full time

    Parexel FSP is looking for a Clinical Operations Manager- FINANCE. This role requires 1-day minimum onsite requirement in Kirkland Quebec. Job Purpose: The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following: - Performance and compliance for assigned...

  • Clinical Operations Manager- Finance

    3 weeks ago

    Montréal, QC, Canada Parexel Full time

    Parexel FSP is looking for a Clinical Operations Manager- FINANCE. This role requires 1-day minimum onsite requirement in Kirkland Quebec. Job Purpose: The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following: - Performance and compliance for assigned...

  • Clinical Operations Manager

    6 months ago

    Montréal, Canada ICON plc Full time

    As a Clinical Operations Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: The Clinical Operations Manager is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to...

  • Clinical Advisor

    6 months ago

    Montréal, Canada Clinical Research Dental Full time

    **Position Summary** This particular role is for an already established Territory in Monteregie Ouest, West Island and Outaouais. Fluent French and English is required. The **Clinical Advisor** (Dental) is accountable for developing sales and providing education within their assigned territory consistent with strategic and corporate goals and values. The...

  • Clinical Operations Manager-regulatory, Fsp

    6 months ago

    Montréal, Canada Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Advisor Dental

    4 months ago

    Montréal, QC, Canada Clinical Research Dental Full time

    **If you have the passion for dentistry, continuous learning, educating and serving a talented clinical audience and making an impact in dental consulting sales, along with the background required, we would love to hear from you!** **Position Summary** This particular role is for an already established Territory in Greater Montreal and surrounding area....

  • Clinic Manager

    6 months ago

    Montréal, Canada Jack Nathan Health Full time

    **POSITION OBJECTIVE**: **FUNCTIONAL/TECHNICAL RESPONSIBILITIES**: 1. Acts as the first point of contact for admins, physicians, and senior management. 2. Supervise the administrative staff. 3. Manages staff scheduling to ensure effective clinic coverage and yield productive results. 4. Oversees and finalizes staff clock in/out using the electronic staff...

  • Clinic Manager

    6 months ago

    Montréal, Canada Jack Nathan Health Full time

    **POSITION OBJECTIVE**: **FUNCTIONAL/TECHNICAL RESPONSIBILITIES**: 1. Acts as the first point of contact for admins, physicians, and senior management. 2. Supervise the administrative staff. 3. Manages staff scheduling to ensure effective clinic coverage and yield productive results. 4. Oversees and finalizes staff clock in/out using the electronic staff...

  • Clinical Research Manager

    6 months ago

    Montréal, Canada Fortrea Full time

    Clinical Research Manager Remote - Montreal, Quebec - The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country...

  • Clinical Research Manager

    6 months ago

    Montréal, Canada Fortrea Full time

    Clinical Research Manager Remote - Montreal, Quebec As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across...

  • Manager, Clinical Support

    6 months ago

    Montréal, Canada Innovaderm Research Full time

    **Manager, Clinical Support, **Head office, Montreal, Qc The Manager, Clinical Support works in close collaboration with the Director, Clinical Research Unit and Clinical staff to manage team and offer support at the various stages of the management of Clinical Research. The manager is responsible to lead the activities and for overseeing the day-to-day...

  • Assistant Manager in Clinic

    6 months ago

    Montréal, Canada Oeil Santé MD Full time

    See if you are our next: **ASSISTANT CENTER DIRECTOR / ASSISTANT CLINIC MANAGER** | 15-month temporary mandate** Eye Health MD (a partner of Vision Group) is a specialty eye clinic offering advanced eye care services and cutting edge technology. It is a leader in its industry, providing world-class eye care and treatment. Our advanced eye care clinics...

  • Clinic Integration Coordinator

    2 weeks ago

    Montréal, Canada Cosmetic Physician Partners Full time

    CPP Clinics is a leading provider of medical aesthetics services, offering innovative treatments across multiple medspas under the CPP umbrella. We are dedicated to delivering exceptional patient experiences and outstanding results, utilizing advanced technologies and personalized care. **Job Title**:Clinic Integration Coordinator **Reports to**: Director...

  • Clinical Manager

    2 months ago

    Montréal, QC, Canada The Native Women's Shelter of Montreal Full time

    **POSITION TITLE**:Clinical Manager** **Duties and Responsibilities** Under the authority of the Executive Director, the Clinical Manager is responsible for the following tasks: - Provide guidance to staff in relation to their clinical duties. - Coordinate and chair weekly case management meetings with the resident psychotherapist - Assign clients to...

  • Clinical Research Manager

    6 months ago

    Montréal, Canada ICON plc Full time

    As a Clinical Research Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country...

  • Clinical Manager

    3 months ago

    Montréal, QC, Canada Native Women's Shelter of Montreal Full time

    **POSITION TITLE**:Clinical Coordinator** **Duties and Responsibilities** Under the authority of the Executive Director, the Clinical Coordinator is responsible for the following tasks: - Provide guidance to staff in relation to their clinical duties. - Coordinate and chair weekly case management meetings with the resident psychotherapist - Assign clients...

  • Clinical Project Manager

    2 months ago

    Montréal, QC, Canada Novartis Full time

    **Summary**: Location: Montreal/Toronto, #LI-Onsite About the role: We are looking for a Clinical Project Manager (CPM) to work within the Health Research & Data (HR&D) team, co-leading our efforts to address the local data gaps and implementation struggles identified within the Canadian healthcare landscape, by developing and implementing effective...