Clinical Data Management

Responsibilities :

• Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports.
• Reviews and assists in the development of study documents drafted by CROs such as data transfer agreements, eCRF Completion Guidelines, and Data Management Plans.
• Ensures the quality of clinical data within the EDC and other databases through data review and data reconciliation processes and communicates any outstanding issues.
• Develops, in collaboration with the CRO, a clean patient tracker.
• Coordinates transfers of SAS datasets or electronic data transfers from CROs.
• Leads database lock process.
• Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents.
• Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practice.
• Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
• Independently serve as the lead point of contact for all data management study-related communications.
• Actively participates in team meetings and presents Data Management concerns risks and issues.

Requirements :

• To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
• Bachelor's degree or equivalent in life science, computer science, or related discipline with years' experience.
• Minimum + years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II or III studies, from start-up through closure.
• Demonstrated proficiency in various EDC Systems within the last years.
• Demonstrated proficiency in the data management processes.
• Experience in managing external EDC vendors for Data Management.
• Understanding of Clinical Data Interchange Standards Consortium (CDISC), CDASH, and SAS terminology.
• Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
• Thorough knowledge of applicable regulatory rules and guidelines.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Able to set priorities and juggle multiple projects and demands.
• Able to think critically and independently and be a proactive problem-solver.
• Able to lead and work independently while exercising initiative, flexibility, and sound judgment.
• Comfortable working with different levels of the company including senior level management.
• Demonstrated proficiency in Microsoft Word, Project, PowerPoint, Office, and Excel.
30+ days ago