Clinical Database Programmer II
Date Posted: Tuesday, 14th of February 2012
Salary: Circa £30,000
Start Date: 12 Mar 2012
Telephone: +44(0)1438 870028
Location: South East UK
Consultant Name: Priya Mukherjee
Sector: Clinical
Description
CK Clinical are currently recruiting for a Clinical Database Programmer II who will provide technical expertise for the conduct of clinical trials, and who will work with minimal supervision to support various programming activities related to clinical systems and/or the applications/systems within eClinical technologies.
Key Accountabilities
* Deliver best value and high quality service.
* Check own work in an ongoing way to ensure first-time quality.
* Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance.
* Proactively participate in quality improvement initiatives.
* Ensure compliance with SOPs/Guidelines/Work Instructions, ICH-GCPand any other applicable local or international regulations and participate in internal/external audits and regulatory inspections as required.
* Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS and other programming language usage and processes within the GRO, biostatistics, and medical areas.
* Provide relevant training and mentorship to staff and project teams as appropriate.
* Assist project teams in the resolution of problems encountered in the conduct of their daily work.
* Coordinate and execute system specific project start-up activities.
* Configure & implement eClinical applications/systems specifically required in a project including but not limited to Medical Safety Reporting (ISIS), ARGUS, CTMS (IMPACT), PMED.
* Execute ongoing maintenance tasks, performance evaluations and tuning of eClinical applications/systems.
* Provide optimum monitoring, support, and maintenance of a reliable, quality, integrated eClinical application/system environment.
* Set up / configure automatic reports for studies within the eClinical applications/systems.
* Execute automatic import and export of data.
* Create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
* Create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
* Create, implement and execute import andexport programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
* Perform small to medium size ad-hoc programming tasks.
Interested applicants will hold a BSc Degree in a Life Sciences/Computer Science/Mathematics discipline (OR Equivalent) and you will hold:
* Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
* Knowledge of the programming and reporting process within GRO.
* Knowledge of^SOPs/Guidelines/WorkInstructions/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
* The ability to learn new systems and function in an evolving technical environment.
* The ability to work together with a team (including international teams as required) as well as independently.
* Proven experience working with at least one system used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting).
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your^application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23707 in all correspondence.
