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Clinical Trials Data ManagementJob Duties Outlined
Provide direct supervision including objective setting performance management education and training of clinical data coordinators with a focus on developing Senior Clinical Data Coordinators.
Plan resource and oversee assigned study data operations and clinical trial activities from study start-up through close-out. Assess staffing needs and ensure balanced workload distribution in collaboration with the Director of Data Management. Mentor team members to prioritize tasks solve problems and develop contingency plans. Delegate responsibilities while maintaining overall ownership. Effectively communicate project findings and priorities to relevant stakeholders.
Manage and report on key project deliverables such as data entry timelines data locks close-out visits and audits by monitoring performance metrics. Provide regular updates to senior leadership study teams and sponsors. Proactively identify address or escalate issues to ensure smooth project progression.
Lead the development and implementation of standardized processes to improve efficiency and quality in assigned projects. Identify project challenges facilitate problem-solving and escalate concerns when necessary to ensure timely resolution.
Develop and facilitate the policies and procedures for remote and on-site monitoring visits.
This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job not an exhaustive list of all possible job responsibilities tasks duties and assignments. Furthermore job duties responsibilities and activities may change at any time with or without notice.
Required Qualifications
Certifications: One of the following:
Certified Clinical Research Coordinator (CCRC).
Certified Clinical Research Professional (CCRP).
Work Experience:
8 years clinical trial management experience within the pharmaceutical industry or academia. Education may be substituted for experience on a year for year basis.
Experience and knowledge of pharma specialty and/or Oncologydata as evidenced by application materials.
Experiencewith Electronic Medical Record charting.
Experience with clinical research databasesandsoftware.
Experience with FDA regulations and GCP-ICH guidelines.
Experience with medical terminology.
Education: Masters degree.
Skills
Collaboration.
Computer skills.
Communication.
Attention to detail.
Time management.
Resume/CV
Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health dental and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance long-term disability insurance and various additional voluntary insurance plans are available. Paid time off including vacation and sick begins accruing upon hire plus ten paid holidays. One paid discretionary day is available after six months of employment and paid time off for bereavement jury duty military service and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. Type: Regular Compensation Statement: The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including but not limited to education experience and training qualifications relative to the requirements of the position and funding. At the University of Kansas Medical Center a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range taking into account the combination of factors listed above. Minimum Midpoint MaximumTime Type:
Full timeRate Type:
SalaryPay Range:
$75000.00 - $115000.00
Required Experience:
IC
The University of Kansas Medical Center (KUMC), a campus of the University of Kansas located in Kansas City, Kansas, offers educational programs and clinical training through its schools of Health Professions, Medicine, Nursing, and Graduate Studies.