Principal Database Programmer

The Principal Database Programmer is responsible for managing all programming aspects of the database (development testing, implementation, maintenance and support of clinical databases and applications) from study start to post database lock for assigned projects. This position works closely with other departments and interfaces directly with the internal team and external teams (e.g., Data Management, Project Management, EDC vendors, clients and third-party vendors) to provide status updates and gather requirements, ensure database is developed, maintained, managed, and that it complies with regulatory guidelines. Responsible for leading the operational study team and programming team members on assigned studies, and study programs. Responsible for operational and technical training to end users and junior staff. Responsible for providing planning estimates for project scope, schedule/timelines, forecasting, and resource requirements.

Main Duties & Responsibilities:

• Maintains responsibility of assigned projects. Ensures on-time delivery, communicates the status of projects to internal teams and study
• Maintains awareness of the key elements of the contract and scope of work for assigned project(s) and communicates status updates to the Project team as necessary.
• Performs project forecasting of hours, and identification of resource requirements and manages project budgets including identification of out-of-scope work and post production changes
• Provides input and guidance to the design of clinical databases to the client and internal teams
• Builds and supports clinical databases
• Develops, tests, and validates programs and clinical database to support client-related projects and third-party applications.
• Provides system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications
• Troubleshoots and resolves software and clinical database problems
• Develops and maintains study-specific validation documents
• Provides support to data management for client-related projects from CRF design to post database close and archival
• May design, develop and validate the Company’s internal applications, client-related projects and third-party applications.
• Participate in software vendor selection
• Participate in conducting EDC demonstrations and trainings
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Supports with onboarding of new hires
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards.
• May require some travel
• Perform other duties as assigned

Requirements:

Minimum Education & Experience:

• Minimum 8 years’ experience
• Bachelors and/or a combination of related experience
• Strong experience in Oncology , experience with Autoimmune diseases would be a strong advantage
• Strong experience with Rave and Veeva
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook .
• Experience in Object Oriented Programming (C#, C++, VBS, etc.)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Proficiency in more than one CDMS system to include building forms, edit checks and complex rule development. Awareness of CRF standards and input to maintenance of standards library. Ability to troubleshoot and support peers with technical issues and build solutions. Broad knowledge of drug, device and/or biologic development and effective data management practices
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills
• Professional use of the English language ; both written and oral.
• Experience in clinical database management system development.
• Experience in a clinical, scientific or healthcare discipline.
• Strong leadership and interpersonal skills

Preferred Education & Experience (optional):

• Experience in a clinical, scientific or healthcare discipline and multiple therapeutic area experience
• Experience in utilizing various Database Programming systems
• Ability to work independently, manage time and create plans to achieve project revenue and business goals
• Ability to work effectively with minimal direction; must be a self-motivated and self-directed individual who enjoys a challenging and dynamic work environment
• Team player willing to collaborate and share knowledge
• Highly organized
• Effective communication, interpersonal and negotiation skills
• Excellent organization and prioritization skills
• Exceptional customer service orientation and proven track record of successful client relationship management