Clinical Data Manager - Katalyst Healthcares & Life Sciences
Cambridge, MA 02114
About the Job
Responsibilities :
- Clinical 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 data completeness and accuracy.
- Participate in and support data cleaning, query generation and resolution and review of medical coding as needed.
- 5+years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience
- 3+ years managing vendor relationships/partnerships in a global environment.
- Must have advanced knowledge of Data Management processes and systems.
- Oncology experience required.
- Solid understanding of CDISC standards required.
- Data Visualization Tool experience preferred.
- Experience using standardized medical terminology, including but limited to MedDRA and WHO Drug.
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment.
Source : Katalyst Healthcares & Life Sciences
