EDC Programmer

Job Summary

ProPharma Group is seeking a skilled EDC Programmer to join our team. As a key member of our Clinical Data Management team, you will be responsible for designing, developing, implementing, maintaining, and supporting clinical database systems.

Key Responsibilities

• Design, develop, implement, maintain, and support clinical database systems.
• Offer technical expertise for internal and external clients.
• Code, test, and document databases as per programming standards and clinical validation policies.
• Program database manipulation and conduct data transfers for clients.
• Review Data Validation Plans and Case Report Forms as per area of expertise.
• Add all external data sources such as PK and central lab within the clinical database if integration is requested or required.
• Serve as programming contact to handle database issues within area of expertise.
• Support development and implementation of new technologies.
• Support Information Technology to evaluate new technology upgrades by participating in software change controls.
• Support development, revision and maintenance of core operating procedures and working instructions pertaining to database development, user acceptance testing and change controls.
• Interface with project team to organize responsibilities and deliverables.
• Establish effective communication and professional relationships with teams and external vendors.
• Interface with Clinical Data Management and corporate team to negotiate timelines.
• Perform administrative tasks within the EDC system, such as site and user management, URL level reviews and/or approvals, and dictionary updates.
• Follow and influence the development of data standards and strategies pertaining to the standards library.

Requirements

• Understanding of the principles of ICH GCP and regulatory requirements is essential.
• Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.
• Minimum BS in a scientific or health related field or equivalent in years of experience.
• Minimum 3 years of experience as a clinical database developer.
• Experience with EDC system Medidata Rave.

About ProPharma Group

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.