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
- Applicants should have a minimum of a Bachelor's Degree in a relevant field of study (Health Sciences, Clinical Research preferred) and 1-3 years of experience in clinical study management
- 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.
- Fluent in reading, writing, and speaking of English
Working Conditions
- Home Based
- Occasional travel
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