Manager, Clinical Operations

  • Manager, Clinical Operations

    Montreal, QC

    Our client, a leading pharmaceutical company is looking for a Manager, Clinical Operations to join their team. 

    Main responsibilities:
    • Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial.
    • Ensure studies are on track for site initiation, patient recruitment, and enrollment, and take corrective actions where necessary to address issues.
    • Develop SOPs and work instructions to assure internal files and clinical study files conform to Good Clinical Practice regulations and standards.
    • Maintain surveillance of published literature/clinical results and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions.
    • Develops budgets for all clinical projects and adheres to company financial goals.
    Qualifications:
    • Undergraduate university degree in life sciences (BSc.)
    • Master’s degree in life sciences or higher, preferred.
    • Minimum of 7 years of relevant clinical research experience in an industry
    • Experience in drug development in oncology, cardiology and/or immunology.
    • Experience in radiopharmaceutical, an asset.
    • Familiar with global regulatory and compliance requirements for clinical research including but not limited to US CFR, EU CTD, and ICH GCP.
    • Excellent adaptability and flexibility.
    • Excellent capacity for analysis, good judgment, and critical skills
    • Capacity to prioritize and execute several projects at the same time and with a minimal supervision.
    • Strong leadership and team spirit
    • Ability to work in a fast-paced environment.
    • Effective communication skills, both verbal and written.

    Please submit your resume directly to Céline Chabée at cchabee@groupelock.com, indicating “Manager, Clinical Operations” in the title of the email.

    Only selected candidates will be contacted.