Job Description
Job Description:
The Data Manager, Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Management & Analysis team within OED and internal colleagues to ensure data integrity and quality for oncology first in human clinical trials up through clinical proof of concept.
Responsibilities:
- Provide CRO oversight and feedback related to the data management operations, issues and trends in performance.
- Completes assignments as delegated by OED Data Management relating to operational objectives and study deliverables.
- Effectively utilizes available technology, EDC platforms, Reporting and Visualization tools.
- Reviews CRO deliverable to ensure adherence to data standards and protocol requirements implemented within the design.
- Reviews study execution documents including specifications, data management plan, data review plan, data transfer plan and other cross functional plans delineating data review needs.
- Provide CRO oversight of data management tasks in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, and query management to identify errors and inconsistencies in clinical data and ensure their resolution.
- Identify and triage issues as they occur.
- Ensures CRO data management adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and to data management quality standards.
Requirements:
- Bachelor's degree in business, management information systems, computer science, life sciences or equivalent.
- Must have at least 4+ years of pharmaceutical, clinical research, data management, health care or other relevant experience.
- Strong understanding of clinical trial processes and clinical technology.
- Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively.
- Strong understanding of GCDMP.
- Demonstrated effective communication skills.
- Demonstrated effective problem-solving skills.
Top Skills:
- Must have at least 4+ years of pharmaceutical, clinical research, data management, health care or other relevant experience.
- Strong understanding of clinical trial processes and clinical technology.
- Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively.
- Strong understanding of GCDMP.
- Demonstrated effective communication skills.
- Demonstrated effective problem-solving skills.