Job Description

Position Overview

Under the direction of the Manager, the CDS Developer is responsible for designing, modifying, and documenting clinical databases and their supporting systems for the support of clinical trials. Demonstrates a working knowledge of the design and development of electronic Case Report Forms (eCRFs), clinical databases and other methods of capturing and transferring data in support of clinical research.

Demonstrates a working knowledge of clinical database development, standards and the development process. Primary customers are Global Data Management Services and Clinical Research.

Primary Activities

Assumes the responsibilities for all database development deliverables including database set-up and edit check programming to support multiple clinical programs. Coordinates and

participates in the following activities:

60% Responsible for the clinical database design activities for startup of a protocol which include design and implementation of clinical database with electronically captured data. Review the technical feasibility of study team proposed edit checks and technically implements them. Work effectively among CDS team to communicate issues and ideas to improve the business.

15% Under proper change management, responsible for change requests and incidence correction into clinical database. Ongoing support in a dynamic and matrix organization.

25% Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.

Requirements

• Bachelor’s degree in computer science or equivalent educational exposure to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.

• Solid experience in database development or data cleaning programming, preferably clinical databases and programming.

• Demonstrated strong technical proficiency in a Clinical Data Management System. Preferably Inform, Inform Architect, Central Designer, SQL-PL/SQL.

• Solid experience with Oracle databases and SQL.

• Solid knowledge of MS Windows/Office software and exposure to web based applications.

• Ability to establish and maintain good working relationships with different functional areas.

• Strong sense of urgency and customer focus.

• Ability to present in a group environment.

• Leadership, verbal and written communication, interpersonal and organizational skills.

• Desire and ability to learn new processes and technologies.

• Knowledge of Clinical Development and Regulatory Affairs requirements.

• Ability to multi-task, work independently, and good communication skills.

• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.

Required Skills:

Preferred Skills:

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Relocation:

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