Job Details: Clinical Programmer Analyst
| Job Title: | Clinical Programmer Analyst |
| Job ID: | 2699 |
| Company: | Edwards Lifesciences |
| Position Type: | Permanent |
| Pay Rate: | D.O.E. |
| Date Posted: | May-08-08 |
Create and maintain accurate documentation of clinical database structures, database conventions, data validation specifications, software user instructions, trial data extract specifications, database test plans and reports, study report specifications and any additional activities during the life of a clinical study to ensure data quality, compliance with regulatory guidelines and company global SOPs.
Implement, manage and maintain a global Electronic Data Capture (EDC) solution for clinical studies. Manage outside EDC vendors to ensure system compatibility, quality, and standards.
Interact with clinical project managers, clinical staff and statisticians to provide support for database activities, such as data exporting, data queries, data review, study protocol/CRF review and new global report generation.
Our Requirements:
*Multi-level position: Position title and level posted is preferred. However, depending on background and experience, we will consider hiring at the Sr. Clinical Programmer Analyst level.
Requires database design experience within a clinical research or clinical data management environment as follows: a minimum of two years for the Clinical Programmer Analyst; a minimum of five years at the Sr. Clinical Programmer Analyst level.
Experience with software application validation, user acceptance testing and process documentation desired.
A bachelor's degree in computer science or related discipline is required.
Requires working knowledge of SQL, Excel, Clinical Electronic Data Capture tools and processes, and relational databases. Knowledge of SAS, MS Access, Medidata Rave a plus. Demonstrated knowledge of clinical trial processes, clinical data management practices, and computer programming required.
Ability to attain, maintain and apply a strong working knowledge of GCPs, applicable SOPs and 21 CFR 11 preferred.
Excellent written and verbal communication skills, strong organizational skills, self-motivated, flexibility and adaptability a must.
Ability to work in a cross-functional team environment, when necessary.
| Location: [rss] | US-CA-Irvine |
| Telecommute: | No (Onsite Position) |
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| URL: | http://www.edwards.com |
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How to Apply: At Edwards Lifesciences, we want you to have as much information as possible before making an important career decision. To find out more about this role and the opportunity it offers, please visit our website: www.edwards.com OR To apply directly to this position, please click the link below or cut and paste it into your browser: http://www.edwards.com/Careers/reqfinder?urlvariablestring=2699 |
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