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Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, set up, maintenance, and close out. Manages the day-to-day data management project activities including, but not limited to timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Managers and Clinical Data Analysts.
- Spearhead study setup including CRF design, database structure development, annotation, document creation and/or approval, data entry screen and edit check testing and approval, etc.
- Proactively plan, allocate and prioritize workloads for multiple projects (to include media control, data entry, pre-entry review and discrepancy management and assessment tasks, as applicable)
- Working independently to oversee day to day data management project activities
- Establish, monitor and maintain timeline for data management responsibilities
- Mentor clinical data managers and clinical data analysts
- Assist other CDMs and CDAs with the management of tasks, timelines and budgets as they pertain to data management activities on projects
- Communicate with cross functional groups throughout the project lifecycle
- Plan and conduct internal and external team meetings
- Participate in presentations to clients, sites, and cross functional groups
- Monitor project budget and project scope, as they relate to data management activities, and communicate project status regularly to senior management
- Provide project team with regular updates on project progress pertaining to data management activities
- Assume full project management responsibility for all data management activities
- Train site coordinators, Clinical Research Associates, and investigators on clinical data entry, discrepancy management, CRF page verification, and CRF page approval processes
- Develop, maintain, and analyze assigned project metrics such as completed pages, discrepancy aging, etc. Establish causes and implement corrective actions for adverse trends that are identified.
- Maintain quality control of the clinical data, project deliverables and closeouts
- Oversee the review of medical coding for validity and completeness
- Adhere to all aspects of SDC’s quality system
- Comply with SDC’s data integrity and business ethics requirements
- Perform other duties as assigned
Skills / Requirements
- Exceptional working knowledge of clinical trials and the data management role in the clinical trials process
- Excellent organizational and project management skills
- Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
- A minimum of 3 years staff mentoring and leadership experience
- Outstanding leadership capabilities
- Strong delegation abilities
- Highly effective written and verbal communication skills in English
- Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products
- Desirable skills include: CRF design, MS Project, involvement with a federal submission (either NDA or PMA), programming skills (SAS, PL/SQL), analytical capabilities, medical coding (adverse events and medical therapies)
- Experience in multiple therapeutic areas (TAs) in clinical trials is mandatory including experience in at least two of the following TAs: oncology, cardiology, central nervous system (CNS), infectious disease, respiratory, endocrinology, gastroenterology
Education or Equivalent Experience:
Master’s degree (preferably in engineering, applied or life science) and at least three (3) years of experience in clinical data management, or a Bachelor’s degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of five (5) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and five (5) years of experience in clinical trials.