Clinical Trials Manager Jobs
By Spectral Medical Inc. At Etobicoke, Ontario, Canada
4 plus years of experience in clinical trial management
Knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements
Oversight and management of day-to-day trial operations including CRO management
Oversight and management of certain sub-studies that may be undertaken from time to time
Management of trials and oversight of day-to-day trial operations (70%)
Management of Study Team Members (15%)
Associate Director, Clinical Project Lead (Late Phase)
By Alexion Pharmaceuticals, Inc. At Mississauga, Ontario, Canada
Communicates clinical studies performance data to other members of the management and scientific team.
Ability to lead cross-functional teams and to provide management oversight of CROs.
Experience in developing study budgets, forecasting and financial oversight of a project.
Oversee third party vendors to operationalize the study specifications.
Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.
Participate in and/or lead departmental initiatives.
Protocol Writer - Clinical Trials
By Pharma Medica Research Inc. At Mississauga, Ontario, Canada
Must possess good computer skills and organizational skills. Experience with an electronic document control and management system would be a plus.
Ensure timely and accurate entries and updates into a computer management system required for clinical conduct.
3 or more years of pharmaceutical related experience in medical writing, preferably in a CRO.
Thorough knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines.
Strong knowledge of medical terminology, clinical trials, and clinical research.
Strong knowledge of processes with a desire to promote improvement. Ability to motivate and energize others with a positive, can-do attitude.
Medical Advisor Clinical Trials 002
By Alexion Pharmaceuticals, Inc. At Mississauga, Ontario, Canada
Minimum 5 years of combined experience in Medical Affairs/Clinical Operations/Clinical Development
Knowledge of the country’s healthcare system and market access environment
Plan and manage complex projects
Knowledge of clinical trial conduct
Previous experience in rare diseases is of advantage
Ensuring appropriate and compliant level of Patient Advocacy Organization (PAO) group involvement with Patient Advocacy team
Clinical Trials Quality Specialist
By Hamilton Health Sciences At Hamilton, Ontario, Canada
Systematic thinker with strong project management and organizational skills
Experience with modifying, implementing, validating, and maintaining a web-based Clinical Trials Management System, including trouble shooting operational problems
Experience with, or certification in Lean or Six Sigma considered an asset
Recognized certification in clinical research (ACRP or SOCRA) preferred
Minimum five (5) years clinical research experience in a health care setting
Minimum three (3) years cancer related experience