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    Study Start-Up Clinical Research Associate

    Novartis
    3+ years
    Not Disclosed
    Montreal
    10 Nov. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Study Start-Up CRA (Remote – Montreal, Canada)

    About the Opportunity
    Join Novartis as a Study Start-Up Clinical Research Associate (CRA) and play a pivotal role in accelerating the start-up of global clinical trials. We're seeking an innovative, agile professional passionate about reimagining medicine and making a difference. This is a remote opportunity based in Montreal, Canada. Note that relocation support is not available, so applicants must be able to access this location.

    Key Responsibilities

    • Collaborate on country-specific Study Start-Up (SSU) strategies with the SSU Team Lead, SSU Manager, Feasibility Manager, and Site Partnership Manager.
    • Partner with global study teams to ensure country-level Study Start-Up timelines and deliverables are met.
    • Oversee site selection and manage timely start-up activities, from country allocation to site greenlight.
    • Conduct site selection visits to verify site eligibility for studies.
    • Serve as the primary contact for trial sites during site selection, start-up, and regulatory submissions (IRB/IEC and HA).
    • Ensure study milestones (KPIs) and timelines are achieved.
    • Assist in the preparation of country-specific documentation, including informed consent forms and patient-facing materials.
    • Support vendor set-up and implement innovative, efficient processes aligned with Novartis' strategy.
    • Prepare sites for "Green Light" approval and collaborate with the SSU Manager for final review and sign-off.

    What You’ll Bring

    Essential Qualifications:

    • Degree in a scientific or health-related field, with experience in clinical operations.
    • At least 3 years of experience in clinical operations, including monitoring or site management.
    • In-depth understanding of clinical drug development, especially in trial start-up, execution, and monitoring.
    • Strong site management skills, including negotiation and problem-solving.
    • Advanced knowledge of international drug development standards (GCP/ICH), regulatory requirements (FDA/EMA), and local health authority regulations.
    • Bilingual proficiency in English and French.

    Desirable Qualifications:

    • Experience in central/in-house or field monitoring roles.

    Why Choose Novartis?
    At Novartis, helping patients and their families goes beyond innovative science. It’s about working together in a community of smart, passionate individuals to create breakthroughs that transform lives.

    Additional Benefits:

    • Discover the many ways we support your personal and professional growth through our comprehensive benefits and rewards program: Learn More.

    Join Our Talent Network:
    If this role isn’t the perfect fit, join our talent community to stay updated on future opportunities: Sign Up Here.

    About Novartis
    Division: Development
    Business Unit: Innovative Medicines
    Location: Remote (Montreal, Canada)
    Company/Legal Entity: Novartis Pharma Canada Inc.

    Novartis is dedicated to fostering an inclusive work environment and diverse teams that reflect the communities we serve. Together, we’re creating a brighter future for patients worldwide.

    Apply now and be part of our mission to reimagine medicine!

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