Director, Clinical Data Management
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Directs the data management function and respective staff in a single office location.
* Line management responsibilities for staff members. Approves courses of action on interviewing and selection, terminations, professional development, performance appraisals, job 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.
* 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.
* Manages the achievement of departmental sales, revenue, utilization and gross profit targets.
* Serves as primary interface between company and sponsors, vendors and other departments in the area of data management.
* Serves as an authority in the design and implementation of data management strategies.
* Oversees the planning, execution, and maintenance of major projects, if required.
* Ensures that all aspects of the Company s data management processes, procedures, and technology are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and international.
* Develops Standard Operating Procedures (SOPs), data management tools, training, department budgets, and staffing requirements.
* Regularly reviews all relevant projects for financial control and operational productivity.
* 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.
* Leads Data Management personnel through audit situations, including closing out audit findings.
* 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.
* 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 the Company at professional meetings or seminars.
Performs other work related duties as assigned. Minimal travel may be required (up to 25%).
* BA/BS degree in Biological Science or a related discipline in the science/health care field or equivalent education and experience.
* Extensive experience in the design and implementation of technical data management systems targeted at supporting large-scale multiple site clinical trials including supervisory experience.
* Experience in a Contract Research Organization or pharmaceutical/biotechnology company preferred.
* Experience in working in a matrix structured environment with multiple product lines. In-depth knowledge of FDA regulations and strong understanding and usage of medical terminology.
* Effective organizational, presentation, documentation, analytical, and interpersonal skills with demonstrated ability to lead and motivate a matrix team.
* Excellent leadership/management skills.
* An appreciation of Project Management skills preferred. Basic computer skills in Word, Excel, and email.
* Ability to handle multiple tasks to meet deadlines in a high stress environment.
* Ability to implement, control, and understand productivity measures and a good understanding of financial control.