Clinical Database Programmer

🔥 0 minutes ago

🇮🇳 India – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🖥 Software Engineer

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead and supervise the design, implementation, and maintenance of electronic data capture (EDC) and clinical database management systems (CDMS) in standard or CDISC-compliant formats • Create, implement, and maintain consistency checks and edit checks in standard or CDISC format • Provide technical leadership and mentorship to programming teams and project staff, including training on eCRF design, database procedures, and clinical data management best practices • Serve as the primary technical contact and liaison with sponsors, data management leaders, and cross-functional teams regarding database programming issues, technical solutions, and project timelines • Manage database lock/unlock procedures and approve database changes in accordance with SOPs • Maintain technical and regulatory documentation for clinical databases, including deviation logs and traceability records • Support the integration and programming of systems within Global Data Operations, including CTMS, safety systems, and coding systems • Execute multiple programming languages and processes • Develop, improve, and implement project-specific tools and standards to enhance efficiency and optimize clinical trial processes across multiple concurrent projects • Participate in business development activities, including bid defense meetings and technical support for new business opportunities • Collaborate with sponsors, data management leaders, clinical operations, and cross-functional teams from study planning through closeout • Ensure regulatory compliance, data accuracy, system optimization, audit readiness, and first-time quality on deliverables

🎯 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 with Custom Function programming will be added advantage • Strong knowledge of SOPs, guidelines, work instructions, SDLC methodologies, ICH-GCP, and applicable regulatory requirements including 21 CFR Part 11 • Demonstrated experience in the clinical research industry or similar regulated environment • Strong communication, organization, and problem-solving skills with proven ability to work independently and collaboratively • Bachelor's degree in relevant science discipline or equivalent work experience (preferred) • Certification in at least one clinical systems platform (e.g., RAVE, DataLabs, Medrio, Veeva) (preferred) • Experience with multiple systems used in clinical trial processes (e.g., CTMS, medical safety reporting systems, or additional EDC platforms) (preferred) • Presentation skills and experience supporting business development activities (preferred) • Immediate availability preferred

🏖️ Benefits

• 6-month contractual assignment • Flexibility • Growth opportunities • Continuous learning opportunities • Opportunity to explore career paths and expand skills across clinical research