Clinical Manager- Halifax, NS or Quebec City, QC

Summit Search Group is excited about a newly created opportunity with our Biotech client looking for a Clinical Manager.

Reporting to the Director of Clinical Research, the Clinical Manager is responsible for the planning, management and execution of clinical trials from start-up to completion/close out. In this role you will be responsible for daily clinical operations and ensuring the close monitoring of all clinical activities, including project liaison with CROs, vendors and business partners. The Clinical Manager is accountable to communicate with and support the clinical investigators.

This opportunity is designed for someone who has experience in the Clinical aspects of Pharma and the Biotech industry, it is not designed for new graduates. This position could be remote, for someone with significant experience.

Responsibilities

  • Participate in the design, planning and implementation of clinical trials.
  • Develop and ensure adherence to clinical trial timelines.
  • Prepare, review and approve trial-related documents.
  • Manage and oversee clinical activities from the start-up to the completion of the trials.
  • Ensure proper communication of study progress to stakeholders.
  • Identify, lead and manage CROs and other vendors.
  • Responsible for the quality and compliance with protocols and study procedures and ensure audit readiness.
  • Collaborate in the development of clinical SOPs and guidelines.
  • Communicate with and support clinical investigators.
  • Participate in the Site Initiation Visits and oversight of CRAs activities.
  • Coordinate and manage the Investigational Product and clinical samples operations.
  • Participate in the analysis of clinical trial results.
  • Oversee and resolve operational aspects of clinical trials in accordance with standard operating procedures (SOP), good clinical practice (GCP) and applicable regulations.
  • Ensure consistency of clinical study and processes across clinical trials.

Qualifications

  • Bachelor or Masters degree in biological sciences or equivalent with work experience
  • Strong understanding and knowledge of GCP and ICH guidelines, FDA 21CFR and Division 5.
  • Experience in clinical research at the site, CRO or Sponsor level.
  • A minimum of 3-5 years experience in clinical development with a minimum of 2 years in the management and coordination of clinical trials.
  • Strong negotiation, communication and organization skills.
  • Highly detail oriented
  • Demonstrated adaptability and empowerment.
  • Sound analytical and problem- solving skills.
  • Must have the capacity to work under pressure and tight timelines, with a demonstrated ability to prioritize multiple competing tasks and demands.

Additional Valuable Experience

  • Oncology experience preferred
  • Experience with CRO and vendor selection (RFP, Bid Defense).
  • Experience in Project Management.

For additional information regarding this unique Biotech opportunity, please contact Cynthia McCutcheon: [email protected]

Summit Search Group would like to thank everyone who applies. Only candidates whom meet the criteria will receive follow up communications.

Job ID

SM138

City

Halifax, NS
Quebec City, QC

Remuneration

Depends on experience

Recruiter

Apply Online

If your qualifications are a match for this position please apply online for immediate consideration. Thank you for your application.

Position:

Clinical Manager- Halifax, NS or Quebec City, QC

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