Director Data Management Job in Raleigh 27604, North Carolina US
job ID: 8190
Position Title: Director Data Management
Working Location: US, Raleigh, NC
Employment Status: Full-Time Regular
Required Experience: 7 years
Required Education: Bachelors Degree
Required Travel: 0
Job Summary:
Directs the clinical data management function and respective staff in a single office location.
Core Responsibilities:
1. Line management responsibilities for staff members. Approves courses of action on interviewing and selection, terminations, professional development, performance appraisals, position description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods. Drives recruitment of operational staff.
2. Manages resource management and maintaining utilization/realization at acceptable levels. Ensures that all projects maintain the correct level of gross profit, that budgets are maintained and changes in scope applied as necessary. Additionally, implements a project review process to ensure that resource, deliverables, scope, quality and budget are maintained appropriately.
3. Manages the achievement of departmental sales, revenue, utilization and gross profit targets.
4. Serves as primary interface between company and sponsors, vendors and other departments in the area of clinical data management.
5. Serves as an authority in the design and implementation of clinical data management strategies.
6. Oversees the planning, execution and maintenance of major projects, if required.
7. Ensures that all aspects of the company’s clinical data management processes, procedures and technology are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and international.
8. Develops Standard Operating Procedures (SOPs), clinical data management tools, training, department budgets, and staffing requirements.
9. Regularly reviews all relevant projects for financial control and operational productivity.
10. Consults with Business Development activities as required. Reviews and approves the Data Management portion of any proposal and budget which dictates the work will be undertaken in the assigned office.
11. Leads Data Management personnel through audit situations including closing out audit findings.
12. Maintains current professional knowledge in fields of information management, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients.
OTHER RESPONSIBILITIES:
Performs other work related duties as assigned. Minimal travel may be required (up to 25%).
Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business. May represent INC at professional meetings or seminars.
Skills Attributes:
Requires a B.A./B.S. degree in the science/health care field or equivalent education and experience, plus extensive experience in the design and implementation of clinical data collection systems targeted at supporting large-scale multiple site clinical trials, with some supervisory experience required. Experience in a Contract Research Organization or Pharmaceutical/Biotechnology company is a plus. Experience in working in a matrix structured environment with multiple product lines is essential. Requires in-depth knowledge of FDA regulations and strong understanding and usage of medical terminology. Ability to handle multiple tasks to meet deadlines in a high stress environment is essential. Requires effective organizational, presentation, documentation, analytical and interpersonal skills with demonstrated ability to lead and motivate a matrix team. Excellent leadership/management skills are a must, and an appreciation of Project Management skills is desirable. The ability to implement, control and understand productivity measures is essential and a good understanding of financial control is deemed a strong requirement. Basic computer skills in Word, Excel and e-mail are necessary.
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