Senior Specialist, Lead Database Developer

Job Description

Clinical Database Developer

Are you ready to leverage your skills in a role that plays an integral part in advancing healthcare and touching lives? At our company, we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating and developing clinical databases and data transfer files. This role provides a unique opportunity to contribute to a team that is delivering innovative solutions for the prevention and treatment of diseases in both humans and animals.

Your Core Responsibilities

• Your primary role will be to create and develop clinical databases and data transfer files, ensuring they align with written specifications.

• You'll be expected to uphold our clinical database standards, SOPs, and Process Guidelines.

• You will have the opportunity to lead and participate in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts that facilitate the transfer of electronic data files into the Clinical Data Management System (CDMS).

• A key aspect of your role will be to collaborate with members of study teams, including external CROs/Vendors, to incorporate study team requirements into all deliverables.

• You will also be involved in developing transformation logic, and scripts that aid in the streamlining of data for analysis and reporting.

• One of the rewarding aspects of this role is the chance to provide ongoing training and development to other Clinical Database Developers on existing standards.

• You will be part of various activities, including task forces, testing new systems, and coordinating CDS technical initiatives.

• Supporting the clinical database manager/supervisor in project planning, manpower projections, and resource allocation across therapy areas will be another key responsibility of yours.

Who You Are

You are ready if you have:

• A bachelor’s degree in computer science or equivalent professional experience in software design, procedural language, development theory and techniques, testing methodologies, and software documentation.

• A minimum of 4 years of database development or data programming experience (Oracle PL/SQL and Object-Oriented Programming).

• At least 2 years of experience in clinical databases development or programming.

• Demonstrated technical proficiency in Clinical Data Management Systems (i.e., Inform, Inform Architect, Central Designer, Medidata Rave).

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

• A strong sense of urgency and customer focus, coupled with the ability to establish and maintain good working relationships across different functional areas.

• Solid project management skills.

• Excellent leadership, verbal and written communication, interpersonal, and organizational skills.

• A strong desire and ability to learn new processes and technologies.

• Broad knowledge of Clinical Development and Regulatory Affairs requirements.

• The ability to multi-task, work independently, and communicate effectively.

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

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

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