About

• 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 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 Advance Diploma/Degree in a relevant field of study, preferable 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.
• Experience working in clinical research at the site level (e.g., as a Clinical Research Coordinator or Clinical Study Manager).
• Direct project management experience in clinical trials or imaging studies.
• Familiarity with site-level operations in clinical research settings.
• Experience in the gastrointestinal (GI) therapeutic area is a plus.
• Minimum 2–4 years of relevant industry experience

• Home Based
• Occasional travel
• *Accommodations for job applicants with disabilities are available upon request