Clinical Trial Lead

1 month ago


Montreal, Quebec, Canada CDS Fortrea Inc. Full time

CDS Fortrea Inc. offers a highly competitive salary of $120,000 - $180,000 per year for the position of Clinical Trial Lead - Oncology Therapeutic Area Specialist.

Job Summary

The Clinical Trial Lead will lead/support studies; be accountable for the clinical/scientific execution of the protocol; be the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites); and act as scientific lead on Clinical Trial Team (CTT)

Key Responsibilities

  • Responsible for trial design and endpoint development in collaboration with CD; collaborates with medical writing to develop trial results communication for investigators
  • Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports, monitoring data issues and central lab reports
  • Sets up/supports SAC, DMC, adjudication committee; provides scientific input to SM for data management activities (e.g. EDC, DRP, CRF's)
  • Protocols/amendments – collaborates with medical writing, participates in governance committee review; authors protocol clarification letters; reconciles and reviews all protocol deviation classifications and assess and prepares protocol deviation list for the CSR
  • May act as mentor to other Clinical Scientists

Requirements

  • Degree in Life Sciences or significant experience in clinical development (> 14 years)
  • BS/BA with 7+ yrs clinical research experience
  • MS/PhD with 5+ years clinical research experience
  • Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required
  • Proven ability to effectively manage multiple complex studies
  • Medical monitoring experience required
  • TA-specific experience in Oncology
  • Excellent Excel and PP skills required
  • Excellent written and oral communication skills


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