Senior Specialist, Clinical Data Management

• Oversees and coordinates clinical database activities for multiple clinical programs.
• Interface with CDS manager/supervisor to assure consistency of technical and process strategies.
• Acts as a technical resource to other members of the group.
• Plans appropriately to ensure adherence to timelines.
• Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
• Creates and develops clinical databases and data transfer files according to written specifications.
• Ensures adherence to clinical database standards, SOPs and Process Guidelines.
• Leads and participates in the review of eCRFs and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).
• Trains new hires and participates in the interview process.
• Provide ongoing training and development to Clinical Database Developers on existing standards.
• Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.
• Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate CDS technical initiatives.
• Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group.
• Provides ongoing clinical database support to other departments.
• Assist clinical database manager/supervisor in project planning, manpower projections and resource allocations across therapy areas.

• 4 years of database development or data cleaning programming experience, at least 3 of which including clinical databases and programming.
• Demonstrated strong technical proficiency in a Clinical Data Management System. Particularly Veeva EDC, Central Designer, SQL-PL/SQL.
• At least 4 years’ 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.
• Project Management skills
• 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
• Broad 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.

Demonstrates expertise in Clinical Database Development and Management, with strong technical proficiency in Veeva EDC, SQL, and Oracle databases. Capable of leading teams, ensuring adherence to clinical standards, and fostering effective communication across functional areas.

• Clinical Database Development
• Veeva EDC
• SQL-PL/SQL
• Project Management
• Clinical Data Management System

• Database Development
• Data Cleaning Programming
• Oracle Databases
• Clinical Database Standards
• ECRF Review
• Edit Check Programming
• Data Transfer Files
• Clinical Database Support
• Regulatory Affairs Knowledge
• GxP Guidelines

• Leadership
• Communication Skills
• Interpersonal Skills Organizational Skills
• Customer Focus

• Clinical Development
• FDA Regulations
• ICH Guidelines
• Drug Discovery Process
• 21 CFR Part 11

• MS Windows
• MS Office
• Web-Based Applications
• Clinical Data Management System