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 :
- years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience..
- 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 too MedDRA and WHO Drug.
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment.
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