Principal Database Programmer
Precision for Medicine is growing and we are looking for an exceptional Principal Database Programmer to join our European team. This is a full-time, permanent position that can be covered fully remotely from our European locations.
Job Summary:
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 adventage
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
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