Associate Director, Clinical Database Programming

Acrosian; Bengaluru; On-site; INR 3,500,000 - 5,000,000; Full time

Job summary

Acrosian seeks an Associate Director, Clinical Database Programming in Bengaluru to provide strategic leadership and operational delivery across global clinical programs. You will oversee EDC databases, edit checks, and global libraries, ensuring compliance with CDASH and regulatory guidelines.

In this CRO-facing role, you will partner with sponsors and cross-functional teams to drive innovation, automation, and scalable programming solutions, including API integrations and AI/ML-enabled data

Qualifications

• Bachelors in CS, life sciences, or related field.
• 5+ years in pharma/CRO/biotech with database programming leadership.
• Deep data management practices knowledge.
• Strong expertise in EDC: Medidata Rave, Veeva Vault CDMS, Oracle InForm, Medrio.
• Experience with CDASH standards and regulatory guidelines (ICH GCP, 21 CFR Part 11).
• Experience with platform accreditation processes and RFPs.

Responsibilities

• Oversee data acquisition delivery including EDC, ePRO, eSource, and related streams.
• Plan, execute, and deliver database programming across global studies.
• Ensure CDASH standards and form/edit check libraries compliance.
• Support oncology data activities and data quality requirements.
• Collaborate with tech partners to implement AI/ML in workflows.
• Lead automation, API integrations, and scalable programming solutions.
• Provide leadership across therapeutic areas and sponsor governance.
• Oversee vendor deliverables and audits readiness.
• Support regulatory inspections and SOP enhancements.

Skills

Database programming leadership

EDC platforms

Medidata Rave

Veeva Vault CDMS

CDASH standards

Regulatory knowledge

API integrations

Data management

Education

Bachelor's degree in Computer Science / Life Sciences

Advanced degree preferred

Tools

Medidata Rave

Veeva Vault CDMS

Oracle InForm

Medrio

Job description

Associate Director, Clinical Database Programming

Location: Bangalore

Hybrid

Reports to: Manager, Clinical Data Management or Biometrics

Function: Clinical Data Management

Employment type: Full-time

About The Role

The Associate Director, Clinical Database Programming is a senior leader responsible for strategic oversight and operational delivery of clinical data acquisition and database programming activities across multiple therapeutic areas and global clinical programs. This role ensures the design, build, validation, and maintenance of highquality electronic data capture (EDC) databases, edit checks, and global libraries in compliance with CDASH standards, sponsor requirements, and regulatory guidelines.

Operating within a CRO servicebased environment, the Associate Director serves as the primary point of contact for sponsors on database programming matters, driving stakeholder engagement, governance, and escalation management. The role requires deep expertise in EDC platforms, strong leadership in multifunctional matrix teams, and proven ability to deliver database programming solutions across diverse therapeutic areas. In addition, the role requires awareness and application of emerging technologies including artificial intelligence (AI) and machine learning (ML) to optimize database programming workflows, automate edit check generation, and enhance data quality monitoring.

Key Responsibilities

• Accountable for Clinical Data Acquisition delivery within assigned area and scope including setup and management of data collection tools and/or acquisition of external data steams including but not limited to EDC, ePRO, eSource, EHR, Real World data and traditional and novel clinical data streams.
• Drive the planning, execution, and delivery of database programming activities including EDC builds, edit checks, custom functions, and integrations across global studies.
• Ensure compliance with CDASH standards, global forms libraries, edit check libraries, and sponsor specific requirements.
• Experience supporting oncology clinical trials is highly preferred, with a strong understanding of the data acquisition, database programming, and data quality requirements specific to oncology studies.
• Drive collaboration with technology companies and external technology partners to evaluate, implement, and integrate innovative solutions, platforms, and emerging technologies into clinical data acquisition and database programming workflows.
• Lead automation and innovation initiatives, including integration of EDC platforms with external data sources and digital technologies through APIs and other scalable integration frameworks to improve efficiency, data quality, and delivery.
• Drive innovation and efficiency through automation, reusable libraries, and adoption of new technologies for predictive edit check design, anomaly detection, and automated quality control.
• Provide strategic leadership in database programming across multiple therapeutic areas, ensuring consistency, scalability, and efficiency in delivery.
• Act as the primary programming contact for sponsors, managing stakeholder expectations, governance processes, and issue escalations.
• Oversee vendor deliverables and ensure alignment with contractual obligations, SLAs, KPIs, timelines, and quality standards.
• Lead inspection readiness activities and represent database programming during regulatory and/or internal audits and sponsor inspections by ensuring database programming deliverables meet compliance standards (ICHGCP, 21 CFR Part 11) and internal SOPs.
• Contribute to the development and enhancement of departmental SOPs, programming standards, and best practices.
• Anticipation, early detection, prevention and management of risks and issues impacting trial and/or departmental deliverables and activities.
• Provide people leadership including recruitment, onboarding, mentoring, performance management, and career development of database programmers.
• Collaborate with crossfunctional teams including Data Management, Biostatistics, Clinical Operations, and Project Management to ensure seamless delivery of programming outputs.

Qualifications

• Bachelors degree in Computer Science, Life Sciences, or related discipline; advanced degree preferred.
• 1215 years of experience in pharmaceutical/CRO/biotech industry with at least 5 years in database programming leadership.
• In-depth knowledge of data management practices (including tools and processes).
• Strong expertise in EDC systems (Medidata Rave, Veeva Vault CDMS, Oracle InForm, Medrio etc).
• Indepth knowledge of CDASH standards, global forms and edit checks libraries, and regulatory guidelines (ICHGCP, 21 CFR Part 11).
• Experience with Medidata and Veeva accreditation processes, including preparation, coordination, and successful completion of platform accreditation activities.
• Demonstrated experience in bid defence and RFP.