VOTRE PROCHAIN CHAPITRE
Project Data Manager – Multi LATAM Location
À propos du poste
• Act as Functional Lead for Data Management and primary internal liaison between Data Management/Operations, Project Management, Clinical Monitoring, and other functional groups
• Coordinate the assigned Data Management/Data Operations team
• Ensure launch, delivery, and completion of Data Management activities and milestones according to contractual agreements, SOPs, guidelines, and regulations
• Provide project-specific training to internal and external audiences
• Manage project finances, including revenue recognition, scope changes, and internal project review meetings, liaising with Finance and Contracts as needed
• Monitor and communicate project progress to sponsors and project teams using status reports and tracking tools/metrics
• Plan, manage, and request resources for assigned projects
• Develop and maintain project plans, specifications, and documentation
• Maintain ongoing documentation and ensure TMF filing is complete and up to date
• Participate in and present at internal, sponsor, third-party, and investigator meetings
• Create documentation for and participate in internal and external audits
• Train and mentor data management staff
• Prepare input for and participate in proposal bid defense meetings
• Maintain proficiency in Data Management systems and processes through regular training
• Perform other related duties as assigned
• BA/BS in the biological sciences or related disciplines in the natural science/health care field, or Registered Nurse; equivalent relevant work experience accepted in lieu of degree
• Clinical data management experience or an equivalent combination of education and experience
• Experience with Clinical Data Management practices and relational database management software systems
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills
• Contract Research Organization (CRO) experience preferred
• Direct exposure to Oracle Clinical, Rave, or Inform systems
• Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication skills
• Strong presentation skills
• Good organizational, planning, and time management skills with ability to multitask under tight deadlines and attention to detail
• Ability to be flexible and adapt to change, work independently, and work as part of a multi-disciplinary team
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment
• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Minimal travel may be required (up to 25%)