Senior Clinical Database Programmer

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee and guide the design, execution, and upkeep of electronic data capture (EDC) and clinical database management systems (CDMS)

• Develop, implement, and uphold consistency and edit checks

• Offer technical leadership and mentorship to programming teams and project personnel

• Act as the main technical point of contact and liaison with sponsors, data management leaders, and cross-functional teams

• Oversee database lock/unlock procedures and authorize changes to the database

• Keep technical and regulatory documentation updated, including deviation logs and traceability records

• Assist with the integration and programming of CTMS, safety systems, and coding systems

• Create and execute project-specific tools and standards to enhance efficiency

• Engage in bid defense meetings and provide technical assistance for new business prospects

• Contribute to study operations from planning through to closeout, ensuring regulatory compliance, data accuracy, and system optimization

⛳️ Requirements

• 6 to 7 years of experience in clinical data programming

• Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)

• Strong understanding of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and relevant regulatory requirements including 21 CFR Part 11

• Proven experience in the clinical research sector or a similar regulated environment

• Excellent communication, organizational, and problem-solving abilities with a demonstrated capacity to work both independently and collaboratively

• Bachelor’s degree in a relevant scientific discipline or equivalent work experience (preferred)

• Certification in at least one clinical systems platform (e.g., Inform, RAVE, DataLabs, Medrio, Veeva) (preferred)

• Familiarity with multiple systems used in clinical trial processes (e.g., CTMS, medical safety reporting systems, or additional EDC platforms) (preferred)

• Strong presentation skills and experience in supporting business development initiatives (preferred)

🏝️ Benefits

• 6-month contractual assignment

• Flexibility and opportunities for growth

• Continuous learning opportunities

• Career paths and chances to expand skills within clinical research