Pharmaceutical Data Coordinator
2 days ago
Job Description:
Clinical Data Manager required to join Clark Davis Associates, Inc. The successful candidate will be responsible for ensuring data management functions are performed in compliance with regulations and according to study protocol.
The Clinical Data Manager will work with involved parties to prepare the Study Data Management Manual according to company SOPs and in compliance with data standards.
This role involves coordinating, leading and performing clinical data management activities for assigned studies in accordance with SOPs and policies and practices.
Responsibilities:
- Coordinate, lead, and perform clinical data management activities for assigned studies in accordance with SOPs and policies and practices
- Monitor data clean-up process performed by CROs from study start-up through data archiving
- Provide data for analysis
- Coordinate activities including medical coding; data validation checks and database snapshot
- Prepare and distribute project status reports to project team and management
- Function as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with SOPs
- Create and maintain project documentation, including but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects
- Design and modify CRF
- Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities
Requirements:
- Implementing clinical data platform
- Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
- Possess excellent communication, and project management skills
- Bachelor's degree in Mathematics, Science or a related field
- 3 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry
- Previous oncology or ophthalmology experience is a plus
- Experience in early phase
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