Covance

  • Start-up Assoc Project Manager (Clinical Operations Manager - Regulatory)

    Job Location(s) CA-QC-Montreal
    Job Number
    2018-22945
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Bilingual - French and English

    Montreal Office-Based

     

    On the Client level:

     

    FINANCIAL (as applicable):

    • Assistance with the ownership of country and site budgets.
    • Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
    • Oversight and tracking of clinical research-related payments
    • Payment reconciliation at study close-out.

     

    COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):

    • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
    • Development of local language materials including local language Informed Consents and translations.
    • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

     

    MANAGEMENT & QUALITY OVERSIGHT:

    • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
    • Contributes to the development of local SOPs.

     

    COLLABORATION:

    • Works in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
    • Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

     

    LOCAL PROCESS OVERSIGHT: (as applicable):

    • Responsible for 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, regulatory, safety and finance systems.

     

    Education/Qualifications

    Minimum Required:

    • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
    • In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting  will be considered
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
    • Thorough understanding of the drug development process
    • Fluent in local office language and in English, both written and verbal

    Experience

    Minimum Required:

    • Good organizational and time management skills
    • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
    • Excellent communication skills, oral and written.
    • Self-motivation with the ability to work under pressure to meet deadlines
    • Works well independently as well as in team environment.
    • Detail and process oriented
    • Positive attitude and approach
    • Interact with internal and external customers with high degree of professionalism and discretion
    • Multi-tasking capability.
    • Good computer skills with good working knowledge of a range of computer packages
    • Ability to lead and develop junior staff
    • Flexible and adaptable to a developing work environment
    • Minimum of four-six (4-6) years of clinical research experience

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