Senior Manager/Associate Director, Clinical Data Management

Senior Manager/Associate Director, Clinical Data Management (Hybrid; Greater Boston, MA)


How you'll make an impact:

• 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.

• 8+ years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience
• 5+ years managing vendor relationships/partnerships in a global environment.
• Must have advanced knowledge of Data Management processes and systems
• Solid understanding of CDISC standards required
• Data Visualization Tool experience preferred.
• Experience using standardized medical terminology, including but not limited to MedDRA and WHODrug.
• Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment.