Perm Clinical Operations Lead – Canada

Category: Clinical Operations Lead
Job #: 10652
Location: Canada
Job Type: Perm
Therapeutics: Oncology

One of our partners is looking for a Clinical Operations Lead to oversee Canadian projects. Qualified candidates will have at least 10 years’ clinical research experience, and at least 3 years’ experience as a fully dedicated regional, home based, field monitor for a CRO or pharma.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
  • Develop and implement site recruitment, selection and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Provide training to other CRAs on the study protocol, study conduct, CRF completion and data management expectations
  • Ensure essential document collection for completeness per regulatory requirements
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs
  • Manage one or multiple studies
  • Monitor product supplies/accountability
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities
  • Review in-house data and study tables
  • Mentor, coach and provide guidance to clinical staff as appropriate
  • Effectively review trip reports as per annotated report, protocol, Sponsor SOPs and monitoring plan, ensuring errors are minimized, reports are consistent across visits and sites and adhere to the highest standards of quality
  • To observe and escalate safety trends in patients as identified in trip reports
  • To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues
  • Track processing time throughout review cycle, ensuring turnaround time of the trip reports adhere to Sponsor SOPs
  • Regular oversight of tracking systems to ensure key metrics, e.g. MVR and FUL timelines, action Items and other quality metrics are being met and followed
  • Compile information and provides status updates to monitoring management and to monitoring staff, as requested
  • Where required, attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends
  • Liaise with CTM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety
  • Ensure all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner
  • Contribute towards quality improvement and risk management plans to minimize impact on project objectives and deliverables, and patient safety and show consistent improvement in metrics
Job Qualifications:
  • Minimum 10 years’ clinical research experience
  • One year of leadership experience is required
  • Minimum Bachelor’s degree required
  • Recent Oncology experience is required
  • Hema/Oncology, Pediatrics, Migraine, CNS/Psychiatry, and/or Multiple Myeloma experience is preferred
  • Approximately 25% travel

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