Clinical Data Manager

Responsibilities :

• Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies.
• Interact and manage relationships with other functional areas to ensure high quality data management activities.
• Oversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines).
• Participate in User Acceptance Testing Activities for the applicable Data Collection Tools.
• Perform Quality Control for the data completeness and accuracy.
• Participate in and support data cleaning, query generation and resolution and review of medical coding as needed.
• Responsible for adhering to the Data Management timelines and budget.
• Provide technical expertise to help in the use of technologies for Data Management and the clinical study team.
• Contribute to the development of lessons learned and best practices as well as help develop SOPs and internal working procedures and process improvement initiatives.
• Contribute to the establishment of systems and tools to help ensure clinical data security and integrity.
• Contribute to the process to identify, evaluate and select external business partners and technology vendors.

Requirements :