Clinical Trials Manager

Posted 7 months ago

Spectral Medical Inc. is looking for a Clinical Trial Manager who can work for us on a permanent full-time basis, managing clinical trials.

Qualifications:

  • 7 plus years’ experience in pharma and/or, biotech clinical research
  • 4 plus years of experience in clinical trial management.
  • CCRP or equivalent is an asset.
  • Experience in critical care studies and renal studies is an asset.
  • Demonstrated success in managing clinical projects from initiation to close out.
  • Knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements.
  • Understanding of the regulatory progression of establishing and maintaining clinical sites.
  • Advanced Microsoft Office Word, Excel and Power point programs knowledge and understanding.

Primary Responsibilities:

  • Track project progress and timelines and its adherence to the project plan
  • Participate in the evaluation of potential clinical study sites.
  • Develop and maintain enrollment plans including tracking enrollment, identifying trends, and implementing action plans to address issues in collaboration with study teams.
  • Track study budgets, reconciliation of payments, and escalate any issues to ensure that investigators and vendors are paid accurately and promptly.
  • Oversee CRO performance of trial management activities.
  • Sponsor representative to accompany CRO for site visits such as PSV, SIV and others as necessary.
  • Oversee study monitoring including reviewing finalized monitoring reports generated by CRO to track site level activities and identify issues, trends, etc.
  • Participate in the review of study protocol amendments, study manuals, informed consent documents, regulatory binders, source document templates, and other study materials.
  • Prepare study reports including Annual Reports, DSMC Reports, and other site communication reports etc.
  • Participate in the preparation of regulatory submissions related to assigned clinical trials.

Spectral Medical Inc. thanks all applicants, however, only those selected for an interview will be contacted.

Job Types: Full-time, Permanent

Schedule:

  • Monday to Friday

Education:

  • Bachelor’s Degree (preferred)

Experience:

  • pharma and/or, biotech clinical research: 7 years (preferred)
  • clinical trial management: 4 years (preferred)

Job Features

PositionClinical Trial Manager
SiteSpectral Medical Inc.
Hours37.5 per week
StatusPermanent Full-Time

Apply Online

Leave a Reply

Your email address will not be published.