Clinical Project Manager

As the primary sponsor liaison and advocate, the Clinical Project Manager will plan, execute, manage, and monitor regional, single modality, or therapeutic area clinical research projects. Utilizing existing templates, processes, and programs as a guide, he or she will adapt/develop, implement, monitor, and be accountable for project protocols, operational plans, risk management, resources, project tools/materials, documents, and timelines. The successful candidate will be managing the day-to-day activities and performance of a multidisciplinary project team, ensuring all decisions align with corporate, industry, sponsor, and regulatory requirements.

• 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.

• 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.

• 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.

• Act as the 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.

• Applicants should have a minimum of one to three years of related work experience with ongoing training, and a three-year College Advanced Diploma/Degree in a relevant field of study, preferably in (Health) Sciences or Clinical Research.
• The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.
• Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
• Ability to engage in continuous learning and self-development.
• Ability to continually foster teamwork.

• Home Based
• Occasional travel