|Job Category||Trades & Technical|
|Position Type||Full Time|
|Application Deadline||November 30, 2021|
|Experience Required||5+ years|
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
Bachelors degree in Engineering, Science or related field
Advanced degree (Masters or PhD) is an asset