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Clinical Trials Project Specialist
1 month ago
Job Summary
The Clinical Trials Project Specialist will be responsible for planning and executing clinical studies in support of corporate objectives. The ideal candidate will have a strong understanding of clinical study development and execution, with excellent analytical, organizational, and communication skills.
Main Responsibilities
• Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget
• Develop and manage study-related documents and materials, including investigational plans, case report forms, and monitoring plans
• Interact with investigative sites through training and ongoing communication to ensure successful execution of the clinical trial
• Conduct clinical trial monitoring, including qualification, initiation, monitoring, and close-out visits
• Oversee the appropriate reporting and documentation of adverse events and protocol deviations
• Manage external vendors/CROs to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
• Participate on cross-functional core project team to ensure clinical deliverables are aligned with corporate objectives
• Develop an understanding of competitive landscapes for assigned products and therapeutic areas
• Demonstrate understanding of medical business functions, products, and procedures
• Assist with data analysis and interpretation of results
Requirements
• Min degree in Science, Life Sciences, Public Health, Health Sciences, Pharmacy, Medicine, or Nursing from an accredited university
• Knowledge of GCP guidelines and applicable regulations and guidelines of clinical research
• Ability to work independently, as well as part of a team
• High degree of accuracy and attention to detail
• Excellent analytical, organizational, and communication skills
