Clinical Data Manager

 

Position Summary

The Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials. This individual collaborates with the Clinical Trial Managers, Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensure all Clinical Operations activities stay within compliance of Company regulatory and legal policies.

Primary Responsibilities

• Represents data management in study team meetings
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution)
• Executes and/or distributes data management metrics, listings, and reports, as required
• Oversight of data management CRO/service providers on assigned studies
• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables

Requirements

• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements

• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
• Able to communicate and collaborate effectively face-to-face, by telephone, and by email
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
• Knowledge of industry standards (CDISC, SDTM, CDASH)
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• 10% - 15% occasional travel

Education and Training

• Bachelors
• 6+ years of CDM experience in the pharmaceutical or biotechnology industry
• CRO management experience a plus
• Prior oncology/hematology experience highly desirable