Clinical Program Manager

Job CategoryTrades & Technical
Position TypeFull Time
Application Deadline November 30, 2021
Experience Required5+ years
Job DurationPermanent
Education RequiredBachelors

Position Overview: The Clinical Program Manager is responsible for strategy, management and execution of the clinical studies / projects for regulatory submission or evidence generation within program(s).
• Determines applicable program or study objectives, strategy, scope and schedule to meet business needs. Develops the project plan in consultation with the cross-functional program or project team, project stakeholders and the clinical team.
• Presents project plans, provides ongoing updates and presents project results to Division senior clinical management.
• Manages and oversees the execution of the clinical program or projects (multiple clinical studies)
• Ensures staff are trained on the requirements of the clinical project and the project plan.
• Manages and directs the clinical team members (clinical project managers, CRAs) working on the clinical program.
• Motivates and develops staff.
• Responsible for ensuring the clinical project is audit-ready at all times (e.g. project team training records, central files, system validation, etc.)
• Ensures adequate monitoring is conducted on all clinical projects.
• Conducts clinical visits to support clinical projects.
• Provides oversight of clinical project to ensure safety concerns and/or adverse events or trends in Field Events Reporting are identified and appropriate responses are developed an executed.
• Controls device distribution and allocation.
• Monitors project reports for accuracy and trending. Projects input to project budgets and project plans,
• Provides clinical scientific support to project teams.
• Evaluates clinical data in preparation of study summary reports for presentations, publications and submissions.
• Develops and implements corrective actions as needed to address any noncompliance issues.
• Communicates with, and provides updates to, specific core teams.
• Other miscellaneous duties as may be required.

Required Education and Experience:
• Minimum of 7 years directly supporting clinical research or similar experience in a medical/scientific area
• Minimum of 10 years managing projects and working with clinical professionals within a team as well as working in a cross-functional project development setting
• High attention to detail and accuracy
• Advanced written and oral communication skills
• Able to manage multiple tasks and priorities
• Proficient knowledge of medical terminology
• Expertise with GCPs and regulatory compliance for clinical trials (e.g. applicable ISO Standards, FDA)
• Strong problem-solving skills
• Bachelor’s degree in Engineering, Science or related field
• Advanced degree (Masters or PhD) is an asset