Director of Clinical Research

  • Director of Clinical Research

    Director of Clinical Research

    Our client is a Canadian organization in the life sciences industry. They have asked Celine Chabee of Lock Search Group to assist them in their search for a Director of Clinical Research to join their team in Montreal. 

    Role:

    The Director of Clinical Research is responsible for the design and implementation of company's Clinical studies. The Director of Clinical Research design protocols which are aligned with our client’s clinical strategy and goals. They may further set up and monitor clinical studies at investigational sites to ensure that studies are carried out according to protocol and in accordance with applicable regulations and the principles of Good Clinical Practice.

    Essential Functions: The following duties represent the principle job duties however they are not all inclusive:
    - Familiarity with appropriate regulations such as Health Canada, FDA and Europe
    - Design and develop clinical protocols to execute the clinical strategy.
    - Independently or in consultation with the Site(s) and/or CRO, coordinate all the necessary activities required to setup and monitor a study, including but not limited to the following:

    1. Conduct pre-study visit:
    Assess study site to ensure, facility, patient population and staff are sufficient to support the protocol; meet with PI and staff to review study requirements (protocol, CRFs, Sponsor policy and procedures, investigator responsibilities, staffing and patient recruitment)

    2. Prepare study applications and submit to regulatory bodies (ex. ITA & CTA for Health Canada) 

    3. Conduct study initiation visit:
    Confirm appropriateness of the IRB/ethics committee as per GCP; train the site on the CRF completion, on the protocol and safety reporting procedure; collect and forward all required study documentation to Sponsor; document visit and send a copy of the report to the site

    4. Conduct routine monitoring visits to include:
    Review protocol compliance; verifies the source data and ensures that it is accurately reflected in the Case Report Form; resolve questions by Investigator/Staff and ensures the validity of the queries sent to the site by the data management group; check/inventory clinical supplies; review communication with the IRB/ethics committee; review study product accountability; ensure that all consents (if applicable) are signed by the patient prior to study entry; follow-up on previous issues; collect all regulatory documents such as CV, MD licenses, IRB approvals etc…

    5. Conduct close out visits to include:
    Review and collect remaining CRFs; ensure that the Ethics committee has be advised of the termination of the study; retrieve clinical supplies and any other study materials; review investigator’s files to ensure that all documents are in order and ready for audit or inspection; review retention policy and publication procedure; review any follow-up requirements that may be required; keep the project manager informed

    Main Responsibilities:
    • Ensure all clinical study initiatives in the US CAD EU
    • Work with the CTO and VP of Business dev. to develop clinical strategies
    • Lead the design of the clinical study protocols with assistance of internal and external experts
    • Engage with KOl to develop new clinical sites
    • Plan the clinical study execution process that would lead to successful execution of the plan
    • Engage with FDA and payers to validate clinical plan
    • Manage all aspects of study from design to final approval
    • Work with Project Manager to ensure site set up, investigator training and policies and policies of relevant regulatory agencies
    • Strive to reduce accelerate recruitment and execution of clinical trials


    Skills and Qualifications:

    Knowledge of:
    • MS Office
    • Requirements of Good Clinical Practices
    • Requirements of Good Documentation Practices
    • Applicable Regulatory Requirements pertaining to clinical research
    • FDA 21 CFR Part 11 for Handling of Electronic Records
    • Dementia and neuro degenerative diseases

    Ability to:
    • Communicate effectively in spoken and written French and English
    • Travel up to 40% of the time during peak periods (international and domestic)
    • Always maintain and exhibit discretion when handling confidential information
    • Make independent decisions and use good judgment
    • Review and evaluate clinical data
    • Plan, organize, and prioritize tasks efficiently
    • Communicate effectively orally and in writing
    • Assume multiple and concurrent tasks and responsibilities
    • Establish and maintain cooperative and effective working relations with sites

    To apply, please submit a copy of your resume in confidence to Celine Chabee via the “apply now” button.