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 :
10+ years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience.
7+ 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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