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

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at so we can investigate and take appropriate action.

Originally posted on Himalayas