Associate Clinical Operations Manager II

4 weeks ago

Kirkland, Quebec, Canada Merck Canada inc Full time

Job Description:

Assistant Clinical Operations Manager II

The individual in this role is responsible for the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and national regulations, company policies, quality standards, and reporting requirements for adverse events internally and externally.

Under the supervision of the Senior Clinical Operations Manager or Clinical Research Director, the individual is accountable for supporting budget/financial aspects, executing and overseeing clinical trial submissions and approvals in the country.

  • Responsibilities include:
  • Supporting country and site budgets. Developing, negotiating, and finalizing Clinical Trial Research Agreements (CTRA).
  • Overseeing and tracking clinical research-related payments. Reconciling payments at the end of studies. Supervising financial systems. Supporting financial forecasting with the Senior COM and other functions.
  • Contributing to the execution and oversight of clinical trial submissions and approvals for assigned protocols in the country.
  • Developing documents in the local language, such as informed consents and translations.
  • Engaging with IRB/IEC and Regulatory Authority for assigned protocols.
  • Managing country deliverables, timelines, and results for assigned protocols to meet country commitments. Ensuring quality and compliance of assigned protocols in the country.
  • Contributing to the development of local Standard Operating Procedures.
  • Coordinating with various roles to ensure national deliverables are achieved for submissions, budgets, contracts, and local milestones.
  • Providing support and oversight to local vendors when necessary.
  • Coordinating local processes, managing clinical and ancillary supplies, import and export requirements, supplies destruction, local filing, archiving, retention, and insurance processes. Updating country information in clinical and financial systems.
  • Ensuring local regulatory and financial compliance. Ability to influence stakeholders and adhere to budget and payment timelines.
  • Collaborating internally and externally on submission and approval-related interactions. Delivering contracts within fair market value. Leading projects adding value to the business when required.
  • Sharing expertise, best practices, and recommendations for improvement. Providing training as needed.
  • Acting as a buddy/mentor.

Skills:

  • Strong IT skills (MS Office, Clinical IT applications) and adaptability to new applications.
  • Knowledge of core clinical systems, tools, and metrics.
  • Excellent verbal and written communication skills in local language and English.
  • Effective coordination, organization, and negotiation skills.
  • Understanding of budget and contract negotiation processes, local regulatory environments, and how they impact study start-up.
  • Ability to influence stakeholders, resolve issues with minimal support, and make independent decisions.
  • Proactive risk management, problem-solving abilities, and quality mindset.
  • Efficient time management, conflict resolution, and high accountability.
  • High-level communication, negotiation, influence, and mentoring skills in French and English.
  • Capacity to focus on multiple tasks and protocols simultaneously.
  • Positive attitude, independence, and self-motivation.
  • Capability to directly influence site staff.

Qualifications & Experience:

  • 2-3 years of Clinical Research experience.
  • Required: Bachelor's degree.

This position will involve a hybrid work arrangement, combining remote work with in-person responsibilities at the Kirkland Head Office as per job requirements.

We value diversity and inclusivity, believing that innovation flourishes in an environment where varied perspectives converge respectfully. We promote an equal opportunity workplace and strive to foster a diverse and inclusive environment.

ID: R293463

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