03/02/2020
Clinical Systems Data Manager
The University of Kansas Cancer Center is seeking a Clinical Systems Data Manager who will manage the development, oversight, and creation of all Electronic Data Capture (EDC) for the Clinical Trial Organization (CTO) assigned Investigator Initiated Trials (IITs). Individual filling this role will work collaboratively with all CTO staff, investigators, the biostatistics team, and KUCC administrative staff in the management and organization of EDC for our IIT Program.
Position Responsibilities:
• Use protocol to build and test electronic case report forms and case report form completion guidelines. Maintain case report form library.
• Schedule and facilitate bi-weekly Data Management study team calls, maintain minutes and follow up on outstanding items.
• Develop a process and workflow on how EDC/CRFs are created for CTO run IITs. This will include responsible parties, timeline’s and tracking of metrics for all assigned IITs.
• Partner with Biostatistics on the output of data. Includes Data Query process/resolution, Data Metric reports and Interim/Final analysis.
• Meet with PI to establish required protocol data points in relation to published research. Also partner with CTO staff to confirm data being collected.
Position Requirements:
• BA/BS in related field required (life sciences, basic sciences, social sciences, healthcare administration, public health, or database design and information management) or BSN.
• Minimum of 5 years’ experience with clinical trials or related experience with knowledge of clinical research process and regulations.
• High level of competency with computer software, including Microsoft Word, Excel and PowerPoint and relational databases.
• Excellent communication and engagement skills with the ability to communicate in a positive and professional manner. Ability to work and speak directly with Physicians and Faculty about their trial designs and study specific endpoints.
• Ability to work well with people across disciplines (clinical staff, investigators, biostatistics, administration).
• Strong problem solving and time management skills, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines. Must be precise, thorough, and reliable.
Preferred Qualifications:
• Experience working with database systems in academic research and/or healthcare environment; preferably Cris/Velos.
• Experience developing, overseeing, and creating EDC case report forms for clinical trials.
• Clinical Trial experience at an academic medical center or university.
• Experience in a medically related field with demonstrated knowledge of medical terminology.
• Previous oncology experience.
KU Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, s*x, s*xual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.
For more information or to apply, please go to: https://jobs.kumc.edu/postings/28890. Feel free to contact: Alana Estes, Senior Recruiter at aestes@kumc.edu with questions.
The role of the Clinical Systems Data Manager is defined as someone who will manage the development, oversight, and creation of all Electronic Data Capture (EDC) for the Clinical Trial Organization (CTO) assigned Investigator Initiated Trials (IITs). This person is responsible for working collaborat...