Clinical Operations Manager – Regulatory – Montreal in Canada

ICON Strategic Solutions

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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 minimal 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

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

To help us track our recruitment effort, please indicate in your cover/motivation letter where ( you saw this job posting.

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