Ke`aki Technologies, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Ke`aki Technologies offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.
Ke`aki Technologies has an exciting opportunity for a Non-Clinical Data Manager. The position will be located at U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Frederick, Maryland. The position requires a favorable NAC background check, and a signed confidentiality agreement.
The Non-clinical Data Manager (NCDM) ensures complete, accurate and consistent data for reporting to the Chief, Regulated Studies, internal divisions, regulatory bodies, clinical investigators, and Chief, Information Services in order to maintain clinical data systems and related processes to complete key missions. The position shall also coordinate with statistician, clinical research associates, database manager and clinical sites as needed to ensure accuracy, completeness, and regulatory compliance of the non-clinical data. A NCDM is involved in the setting up, running and reporting of non-clinical trials. The NCDM processes data using a range of computer applications and database systems to support collection, cleaning and management of non-clinical data. The NCDM interacts with clients as necessary to establish data review guidelines and data flow procedures.
The NCDM shall ensure that all data collection and reporting requirements specified by each protocol sponsor are completed; and essentially be the POC for all protocol data related communications between USAMRIID and USAMMDA (protocol sponsor). The NCDM shall act as team leader for the Non-Clinical Data Management Team. The NCDM shall design project plans the cover the entire lifecycle of non-clinical database design, implementation, data collection, and data reporting. The NCDM shall analyze protocol requirements and set priorities for the NCDM Team, as well as the Data Entry Team. The NCDM also provides the central means of communication among the Protocol Team, Sponsor, Database Developer Team, and USAMRIID management.
The NCDM shall consult with customers on applicable USAMRMC/USAMRIID/
Department of Defense regulations, policies, pamphlets and Standard Operating Procedures (SOPs). The contractor employee shall have a Bachelor's degree in related scientific discipline; Five to eight years related industry experience or equivalent. The contractor employee shall have experience in using Non-Clinical Database Management Systems and/or LIMS is helpful but not required. Experience using Discoverer is desired.
The contractor employee shall be able to perform the following specific tasks:
Coordinate all NCDM tasks for a project including the development of Case Report Forms (CRFs), CRF completion guidelines, Data Management Plan (DMP) and other NCDM required documents.
Develop and implement project specific data entry processes and non-clinical data management guidelines based upon client needs and requests.
Develop and implement plans for the processing of data within established timelines and budget specifications, and make necessary adjustments based upon project and client needs.
Perform database testing and testing of edit check programs.
Manage data entry processes for studies; develop data entry guidelines, train data entry staff on study specific processes and set-up, and make necessary modifications based upon feedback.
Review Case Report Forms for consistency and clarity, generate and resolve data queries.
Provide analysis and feedback (questions, issues and possible resolutions) to Management and/or project team
Communicate with all departments as necessary regarding project status/issues.
Enter and/or verify data into database system as needed; perform auto-encoding procedures and/or quality control procedures.
Oversee database quality control audit, document database audit finding and generate database audit error report.
Oversee the set up and maintenance of Biometrics central files.
Provide service (routine and ad-hoc reports) to end users in the Office of Regulated Studies.
JOB TYPE: Full-Time
FLSA STATUS: Exempt
Ke`aki Technologies LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.
For additional information on Ke`aki Technologies, LLC, please visit www.keakitech.com .
Ke`aki Technologies, LLC is proud to be an Equal Opportunity Employer/Affirmative Action Employer (EEO/AA) and applicants will be considered without regard to race, color, religion, age, sex, disability, national origin, marital status, or genetic information.