Manager Clinical Operations

Description

• Manage the day-to-day activities necessary for the successful completion of clinical programs according to company Standard Operating Procedures, ICH Guidelines and GCP.
• Line management/mentoring responsibility. May serve as a supervisor for junior clinical staff.
• May have some site monitoring responsibility.

• All aspects of designated clinical protocol(s) with accountability for meeting timelines, budgets and quality standards.
• Anticipates project requirements and institutes appropriate actions to ensure timelines and project goals are met.
• Oversight of designated activities outsourced to CROs, external consultants, central and specialist labs and other vendors
• Provide status reports and acts as primary contact for management regarding project activity.
• Manage the development of clinical trial protocols, case report forms, clinical trial reports and other clinical documents, as required.
• Review, develop and implement all operational and project plan(s) for assigned studies.
• Serve as point of contact for internal departments and external vendors
• Develop the Monitoring Plan and ensure appropriate quality and timely monitoring of clinical sites.
• Review trip reports and other aspects of site monitoring including, performance metrics and quality. Identify, troubleshoot and resolve issues pertaining to site monitoring for in-house and CRO monitored studies.
• Oversee study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation.
• Manage clinical follow-up of quality assurance audit reports.
• Organize and conduct investigators' meetings.
• Manage individual and team performance standards. Identify training, development and recognition needs of project team.
• May conduct pre-study, initiation, routine monitoring and closeout visits of study sites, when necessary.

• University/college degree (life science preferred)
• Thorough knowledge of CRFs, ICH Guidelines, GCP and the clinical trial process.
• Insight of study budget process including:
  • Vendor and Investigator agreements and contracts.
  • CRO budgets, invoicing and payments
  • Site budgets and payment administration
• Understanding of data management, statistical programming and regulatory affairs sufficient to perform project management responsibilities.

• Minimum 7-years of relevant pharmaceutical industry experience including demonstrated skills and competency in monitoring and clinical project management tasks.
• Ability or potential to manage clinical projects with minimum supervision.
• Ability to work within a project team and lead or potential to lead a project team.
• Ability to train / supervise and mentor junior staff.
• Good planning and organizational skills.
• Excellent verbal and written communication skills.
• Good computer skills with good working knowledge of a range of computer packages.