Clinical Database Developer

Purpose: Aerotek Scientific has a need for a Clinical Database Developer at our client located in Cambridge, MA!

Position Title: Clinical Database Developer

Job Description/Responsibilities:

The Technical Data Consultant will support the Study Services group and will be responsible for technical design, documentation, and implementation of clinical data studies. This person will provide technical study start-up support which may include the following tasks: CRF design; CRF annotation; database design/testing; edit check specifications/testing; and documentation development. Additionally, this person may provide: technical consultation to clients; database design and administration; and technical support. This position will report directly to the Director of Study Services.


Principal Responsibilities (other duties may be assigned):
-Provide clinical applications programming for clinical data studies.
-Author technical programming specifications.
-Develop and maintain technical study documents supporting database design and testing efforts.
-Program and maintain all code as defined in specifications or change requests.
This may include: CRF design, CRF annotation, database design/testing, edit check specifications/testing, documentation development and training services (remotely and on-site).
-Document and test all programming and changes.
-Work with Technology Group to develop standard/reusable deliverables and communications.
-Provide expertise, leadership, and knowledge in the technical support areas of Clinical Research tools and practices.
-Execute software validation and record validation results. Review validation scripts for errors and appropriate workflow.
-Provide Technical Support with the following duties:
Document and prioritize support requests according to the client?s requirements.
Consult with the client to troubleshoot and implement technical solutions related to study database design, configuration, and programming.
Troubleshoot and escalate issues related to software errors.
Continuously improving support services to ensure a high degree of client satisfaction such as knowledge building, FAQs, etc.

General Responsibilities:

-Assist in the development and maintenance of SOPs/Guidelines.
-Assist in audit preparation and delivery.
-Ensure company and departmental SOPs, procedures and policies are followed.
-Assist with other client business area responsibilities as requested.

Skills:
-Solid understanding of Clinical Data Management Software (i.e. Clintrial 4, Oracle Clinical)
-Intermediate to advanced programming experience in PL/SQL
-Advanced knowledge of SQL
-Understanding of the Oracle RDBMS
-Understanding of the Windows platform (2000/2003/XP)
Familiarity with Adobe PageMaker? or other DTP program
EDC experience a plus


Travel requirements: approximately 25% average per year

Education/Experience:

This position requires a BS in computer science or related degree or at least 3-6 years of relevant data management, technical and industry experience. This position also requires:

-Knowledge of FDA regulatory requirements
-Knowledge of Good Clinical Practices (GCPs)
-Successful management of multiple projects and resources
-Expert knowledge of technical concepts in the area of Clinical Data Management
-Well-developed problem-solving and decision-making skills
-Ability to communicate clearly and effectively (both written and oral communication)
-The ability to work in a remote team environment
-A highly organized self-starter with excellent interpersonal skills, leadership, communication and organizational skills

If you are interested in applying for this opportunity, please contact Andrea Chruney at (781)356-6916 or email your resume and a reference list to