Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout. 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 Analysts.
- Lead study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
- Allocate and prioritize workloads for multiple projects (media control, data entry, pre entry review and query management tasks)
- Serve as a primary resource for issues pertaining to data management
- Serve as an interim resource for issues pertaining to the study in the absence of the Senior Clinical Data Manager or other SDC management
- Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities
- Mentor all levels of Clinical Data Analysts in their job responsibilities
- Maintain quality control of the data, project deliverables and closeouts
- Oversee the review of medical coding for validity and completeness
- Assume any task outlined in all levels of the Clinical Data Analyst job descriptions, as needed
- Adhere to all aspects of the SDC's quality system
- Comply with SDC's data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
Skills / Requirements
Required Skills and Attributes:
- Exceptional working knowledge of clinical trials and data management role in the clinical trials process
- Excellent organizational skills
- A minimum of 1 year staff mentoring and leadership experience
- Strong leadership capabilities
- Strong delegation abilities
- Highly effective communication skills, both written and verbal
- Technical skills including: Oracle clinical or other relational databases, Microsoft Office
- Additional required skills include the following: CRF design, MS Project, and analytical capabilities.
Education or Equivalent Experience:
- Master's degree in engineering, applied or life science and at least six (6) months of experience in clinical data management or a Bachelor's degree in engineering, applied or life science and a minimum of five (5) years of experience in clinical trials.