Project Management / Project Coordination / Data Management
Coordinate and manage activities and resources in support of the project team for multiple projects simultaneously. Interact with internal departments including operations, data management, and clinical to execute daily tasks associated with providing clinical data monitoring and management to sponsored pharmaceutical clinical research trials.
Required Experience, Knowledge, Skills:
- Minimum of a 4 year Bachelor's degree. Life sciences or related field a plus.
- Minimum 1-3 years' experience in clinical research and clinical trial coordination/management.
- Experience in central nervous system (CNS) trials a plus.
- Bilingual a plus.
- Working knowledge of GCP and CFR's relating to clinical research and data systems.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Excellent organization, attention to detail, time management and problem solving skills.
- Knowledge of or ability to understand, the client needs and project objectives.
- Computer proficiency including excellent skills in Windows with Microsoft Office system and applications, specifically, Excel, PowerPoint, Outlook and Word. Experience with Sharepoint a plus.
- Comfortable and experienced managing daily project workflow through online automated systems.
- Opportunity to work from home as well as from the office. Ability to work independently.
- Support the project team during study start-up, maintenance and close-out phases.
- Execute and test data transfers to ensure internal and sponsor technical requirements are met.
- Responsible for managing day-to-day operations and communication with research sites, sponsor, and study contacts. Identify and effectively communicate inquiries or issues appropriately utilizing escalation plans for communication as necessary.
- Work with local site and sponsor teams globally to initiate and facilitate communication between Cronos Clinical Specialists and site raters. Navigate complexity and logistics of global working teams.
- Prepare client data so as to facilitate clinical analysis in the timelines specified.
- Organize, attend and participate in internal team meetings as well as external meetings with sponsors.
- Prepare and/or edit meeting minutes, presentations, and tables.
- Maintain and contribute to team collaboration workspaces.
- Alert appropriate team members of potential timing and resource issues.
- Support Operations and Clinical to develop workflow processes including related training materials.
- Track and store all study correspondence and materials according to company guidelines and SOPs.
- Support QA activities during internal and external client audits.
- Test project specific systems, user acceptance testing.
- Document and train on unique project computer systems; develop internal training materials and conduct internal training.