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| Job Title: |
Manager, Clinical Data Management |
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Job Location:
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Raleigh - North Carolina - USA |
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Job Category:
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Data Management
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Job description:
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Supports the work of the Clinical Data Associates/Lead Data Managers. Mentoring, developing training plans, and project support are among those duties. Using a strong knowledge clinical data management, oversees all data management aspects of multiple studies, including study documentation, timelines and staffing to ensure data integrity. Interacts with study sponsors on a regular basis to maintain positive relationships. Complies with all Standard Operating Procedures (SOPs)/ Work Instructions (WIs), regulatory guidelines and directives, and study specific plans pertaining to collection, review and management of clinical study data.
ESSENTIAL JOB FUNCTIONS:
Administrative Management
• Mentors, motivates and supervises data management staff , including Lead Data Managers
• Signs time off requests and timesheets
• Performs performance reviews, coaching, and disciplinary actions
• Maintains staff awareness of evolving working practices/policies/work instructions
• Monitors productivity and quality of data management staff
• Assigns tasks to team members, based on ability, and at their discretion
Technical
1. May function as a Lead Data Manager on one or more studies.
Project Management
2. Represents data management in project related cross-functional study team meetings.
3. Manages sponsor relationships for all studies assigned.
4. Holds regular data management team meetings to communicate study information.
5. Performs cross-functional communications where issues are judged to need clarification and /or resolution.
6. Provides and manages projections and actual project budgets for assigned studies under the guidance of the Group Manager/Director.
7. May provide support to Business Development staff by participating in presentations to sponsors.
8. Participates and may lead in the development of departmental processes, work instructions, and standard operating procedures.
9. Participates and may lead in the development of departmental and company wide training programs.
10. Participates and may lead in the implementation of new technologies and services.
11. Performs Clinical Data Associate duties as needed.
OTHER DUTIES:
Performs other work related duties as assigned. Moderate travel may be required (up to 25%). |
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Skills:
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Requires a minimum of a B.S./B.A. degree in the biological sciences or related disciplines in the natural science/health care field or equivalent plus a minimum of 5 years directly related data management experience, or AA/AS and 7 years of health care or clinical research experience with 5 years directly related data management experience or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job. Some experience supervising staff is desired. Advanced degree is preferred but not required. Solid judgment and tactful discretion are required.
Working knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices is required. Requires effective oral and written communication skills, presentation skills, and attention to detail. Experience with relational database management software systems is required. Requires proficiency in Word, Excel, and Email. Ability to multitask under deadlines, and work as part of a multidisciplinary team as well as independently. Ability to be flexible and adapt to change. |
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Bachelors |
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Experience (year):
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5 |
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Post Date:
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09/07/2008 |
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| Contact Information |
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Address:
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<a href="http://trials.in.ua">clinical research</a> 01033 - Ukraine |
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