Clinical Project Manager

4 weeks ago


London, Canada Alimentiv Full time

JOB INFORMATION

Position Title: Clinical Project Manager (Full-time, Permanent)

Position Location: CAN/US

Position Reports To: Project Director

Department/Unit Name: Medical R&D

JOB SUMMARY:
GENERAL AREAS OF RESPONSIBILITY:
Project Management
- Manage the planning, execution, progress and completion of assigned clinical research projects.
- Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies.
- Maintain operational, financial and regulatory integrity and safety.
- Develop and/or participate in the development of project communications, training, regulatory submissions and/or audits and selection of third party vendors as required.

Documents and Tools
- Manage a cross-functional team to ensure the appropriate creation, delivery, maintenance and disposal of all related data, documents, equipment and tools, including protocols, SOPs, informed consent forms, case report forms and instructions.
- Prepare investigator updates and other project related reports as required to support the proper conduct and execution throughout the life cycle of assigned projects.

Project Team Performance
- Identify, assign and monitor the completion of interdisciplinary project tasks that include site monitoring, CRF and database development and revision, data collection, patient safety/adverse event management, document management, statistical analysis and/or final report writing and publications.
- Ensure task completion performance meets or exceeds quality standards and sponsor/client, project and regulatory expectations and guidelines.

Client/Sponsor Support
- Act as primary liaison throughout the project life cycle ensuring client/sponsor expectations are appropriately managed by addressing and resolving queries/issues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsor/client with project status and update reports.

QUALIFICATIONS:
WORKING CONDITIONS:
Home Based

Occasional travel
- Accommodations for job applicants with disabilities are available upon request



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