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:

• 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 .