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For your reference, we have included the original job posting below.
Oracle Clinical Developer
Job Number:
43879182
Company Name:
Kelly Services
Job Location:
Mansfield, MA US
Job Category:
Information Technology
Oracle Clinical Developer
SUMMARY OF POSITION : This person will execute Oracle Clinical study development activities in conjunction with the requirements of Medical Affairs, Clinical Affairs and Data Management. Core responsibilities of the position may include development and design of study databases, creation of validated reports, programming of validation and derivation procedures, and quality control of all deliverables. The successful candidate will have a commitment to delivering the highest quality work, a strong sense of task ownership, and the ability to excel in a fast-paced and team-oriented environment.
ESSENTIAL FUNCTIONS : 1. Set up study data definition - DCM, DCIs, Data Extract Views, etc. 2. Create Graphic Layouts for RDC Onsite Studies 3. Create annotated CRF/eCRF, as necessary 4. Program Oracle Clinical validation and derivation procedures to meet study-specific requirements 5. Support batch loading activities of legacy data in various formats into Oracle Clinical 6. Create ad-hoc reports, as necessary 7. Alpha test and document the QC of all deliverables 8. Participate in the creation, maintenance and update of development standards and best practices 9. Assist in troubleshooting operational issues to resolution, while maintaining good compliance practices 10. Work with team members from Medical Affairs, Clinical Affairs and Data Management to enhance the OC study creation, extraction and transfer process 11. Document activities and work according to SOPs and work instructions 12. All other projects as assigned
MINIMUM REQUIREMENTS :
Education required/ preferred: BA/BS degree in computer or life science or equivalent combination of education and experience. Experience: Minimum of 3-5 years development experience required in Oracle Clinical. Experience with Oracle Clinical's Remote Data Capture Option ( RDC Onsite). Expert-level development skills in PL/SQL. Requires knowledge of systems development life cycle, relational databases and clinical trials database design, development and maintenance. Knowledge of ICH /GCP/FDA regulations and guidelines as they pertain to clinical data management. Preferred Skills/Qualifications: Clinical Data Management experience highly preferred. Preferred therapeutic areas of experience in medical device industry. Skills/Competencies: Toad software experience, SQL Plus, Understanding of Oracle database administration best practices Other Skills: Requires strong oral and written communication and project management skills. Capability to provide technical support, train users, and generate documentation is important. Time management, attention to detail, and organizational skills are crucial. Creative thinking and ability to solve problems while multitasking are imperatives. Ability to complete tasks without close supervision is a must. ORGANIZATIONAL RELATIONSHIPS/SCOPE : - Reports to Manager, Clinical Systems - Interacts with key stakeholders to ensure the highest functionality and usability of study databases and to contribute to process improvement within Medical Affairs, Clinical Affairs, and Data Management - Possible interaction with outside Clinical Research Organizations
