- Lead all aspects of clinical data management for all concurrent projects from clinical study start-up to conduct and study closeout.
- Act as a consultant in data management processes and principles for all projects and other functional groups.
- Define and lead project management activities for multiple complex projects to bring clinical studies on-line Provide training, mentorship, and guidance to other clinical data managers and/or cross-functional members.
- Lead the data cleaning plan according to DMP (Data Management Plan), SOPs, and associated documents, for assigned studies/projects, using the clinical data management system, listings, and reports.
- Responsible for data management milestones and deliverables and ensure that quality standards are met on assigned projects within the department.
- Define, develop, and/or review the creation of essential Data Management deliverables including data management plans (DMPs), data transfer specifications, eCRF Completion Guidelines, training materials, and user aids, etc.
- Identify and make recommendations on trends in data discrepancies and remediation, including developing instruments, and training requirements across studies and therapeutic areas to ensure uniformity in approach and execution.
- Provide data management solutions/guidance and risk mitigation approaches to project teams for operational issues through the use of available data, tools, feedback, and discussions.
- Review, create, maintain, and implement SOPs, work instructions, process improvement initiatives, best practice, lessons learned, and other general workflow optimization with respect to data management function to ensure compliance, accuracy, and efficiency across functional areas.
- Manage CDM related requests from external stakeholders (e.g., regulators, notified bodies, non-governmental agencies, core labs, independent study committee, and auditors).
- Collaborate with vendors and internal teams to define and develop integration (data & process) specifications for the clinical trial database.
- Review clinical protocols to ensure data requirements are sufficient to support study purpose and study endpoints.
- Oversee the build of statistical and data management file infrastructure.
- Work with Biostatistician to program and verify statistical analysis programs.
- Lead the implementation of project documentation per client’s procedures.
- Collaborate with biostatisticians to develop and finalize SAP and respond to statistical analysis considerations.
- Perform audits of biostatistical and data management documentation and file directory.
- Oversee the compilation of statistical analysis documentation for regulatory submissions.
Education and Experience:
- This job requires a bachelor’s degree in related field with eight years of previous related experience in clinical research including clinical data management or Master’s Degree or equivalent in related field.
- Experience with EDC (Electronic Data Capture) systems and software testing in clinical research or clinical data management environment is required.
- Experience authoring DMPs, SOPs, and training materials is required.
|Job Category||Clinical Data Management|