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
