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13 days old

Clinical EDC Developer

Kelly Services
Santa Ana, CA 92702
**Clinical EDC Database Developers in Santa Ana, CA**


Kelly Services is currently seeking 2 Clinical EDC Database Developers for one of our top clients in Santa Ana, CA.


**These are both long term contract positions; manager prefers for candidate to live in the Orange County/Santa Ana area. However, for the right candidate manager is open to this being a 100% remote role.**


Currently seeking 2 experienced Clinical EDC Database Developers for our client, an American/Multinational Corporation that develops medical devices, pharmaceuticals, to work in their world class surgical vision research and development division.


Our clients research data management environment utilizes two Electronic Data Capture (EDC) Systems. In order to support both critical systems and data development, they are looking for one developer that must be well-versed in Medidata Rave, and the other, to be experienced with IBM Merge/EDC.


**Responsibilities:**


Building, maintaining and deploying study databases to collect clinical trial data, including configuring custom integrations.


Managing work assignments to ensure timely delivery of study databases.


Working with Data Management to develop appropriate timelines for development and deployment of study databases.


Identifying and resolving issues which may negatively impact delivery of study databases. Escalating issues to leadership as needed.


Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.


Contributing to the development and application of smart systems and optimal approaches to support the collection of data.


Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.


Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing database development services on behalf of BMS.


**Deliverables Expected for Each Individual:**


Develop EDC databases and related modules


Perform QA / UAT of Clinical Study builds


Perform mid-study changes


Perform Clinical Study Database Lock activities


Perform Clinical Study Database data export activities


Other related tasks to support Clinical Operations


**Qualifications:**


Bachelors degree required with an advanced degree preferred


At least 5 years of database development experience in Medidata RAVE. OR At least 5 years of database development experience in IBM Merge/EDC


_ Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection._


_ Strong knowledge of GCP/ICH guidelines._


_ Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles._


_ An understanding of database and dictionary structures (e.g. MedDRA, WHODrug)._


_ Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks._


_ Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)._


**_Apply Today!_**


_*Available for purchase and administered by a designated third-party vendor._


**Why Kelly** **** **?**


By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-09-03 Expires: 2021-10-14

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Clinical EDC Developer

Kelly Services
Santa Ana, CA 92702

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