Clinical Database Programmer

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

📋 Description

• Oversee and manage the design, execution, and upkeep of electronic data capture (EDC) and clinical database management systems (CDMS) compliant with standard or CDISC formats.

• Establish, implement, and uphold consistency checks and edit checks in alignment with standard or CDISC specifications.

• Offer technical guidance and mentorship to programming teams and project personnel, including training on eCRF design, database protocols, and best practices in clinical data management.

• Act as the main technical point of contact and liaison for sponsors, data management leaders, and cross-functional teams concerning database programming challenges, technical resolutions, and project timelines.

• Oversee database lock/unlock processes and authorize database modifications in line with SOPs.

• Ensure the maintenance of technical and regulatory documentation for clinical databases, including logs of deviations and traceability records.

• Assist in the integration and programming of systems within Global Data Operations, such as CTMS, safety systems, and coding systems.

• Utilize multiple programming languages and processes effectively.

• Design, enhance, and implement project-specific tools and standards to improve efficiency and optimize clinical trial operations across various concurrent projects.

• Engage in business development activities, including bid defense meetings and providing technical support for new business ventures.

• Collaborate with sponsors, data management leaders, clinical operations, and cross-functional teams throughout the study lifecycle from planning to closeout.

• Ensure compliance with regulations, data integrity, system optimization, audit preparedness, and deliverables of first-time quality.

⛳️ Requirements

• 2 to 9 years of experience in clinical data programming.

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

• Experience in Custom Function programming is a plus.

• In-depth knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and relevant regulatory requirements including 21 CFR Part 11.

• Proven experience in the clinical research industry or a similar regulated setting.

• Excellent communication, organizational, and problem-solving abilities, with a demonstrated capacity to work both independently and in collaboration with others.

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

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

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

• Strong presentation skills and experience in supporting business development activities are preferred.

• Immediate availability is preferred.

🏝️ Benefits

• 6-month contractual assignment.

• Flexibility.

• Opportunities for growth.

• Continuous learning opportunities.

• Chance to explore career paths and broaden skills within clinical research.