- Associate Director, Clinical Database Programming

Associate Director, Clinical Database Programming

Location

Bangalore

- Hybrid

Reports to Manager, Clinical Data Management or Biometrics

Function

Clinical Data Management

Employment type

Full-time

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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 high‑quality electronic data capture (EDC) databases, edit checks, and global libraries in compliance with CDASH standards, sponsor requirements, and regulatory guidelines.

Operating within a CRO service‑based 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 multi‑functional 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

Principal 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 solid 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 (ICH‑GCP, 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 cross‑functional teams including Data Management, Biostatistics, Clinical Operations, and Project Management to ensure seamless delivery of programming outputs.

Qualifications

Required

- Bachelor’s degree in Computer Science, Life Sciences, or related discipline; advanced degree preferred.
- 12–15 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).
- In‑depth knowledge of CDASH standards, global forms and edit checks libraries, and regulatory guidelines (ICH‑GCP, 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, RFI processes, including solution development, effort estimation, client presentations, and responding to technical and operational requirements.
- Proven experience managing multi‑therapeutic area portfolios and global database programming delivery.
- Demonstrated success in stakeholder management, governance, and escalation handling.
- Project, risk, and team management and an established track record leading teams to successful outcomes.
- Excellent communication, leadership, influencing, decision making and client‑facing skills to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments.

Preferred

- Oncology experience, preferably across complex global clinical trials.
- Experience collaborating with technology companies or external technology partners to implement innovative clinical data solutions and integrations.
- Experience with API-based integrations, EHR/EMR, eCOA/ePRO, real-world data, and other digital clinical data sources is preferred.
- Experience with Medidata Rave, real‑world data, digital health technologies, and EHR/EMR integration.
- Prior CRO experience managing multi‑sponsor portfolios.
- Track record of driving process improvement and automation initiatives leveraging AI/ML models and technologies.

What We Are Looking For
- A strategic thinker with a hands-on leadership approach.
- A strong people leader with a track record of building and developing high-performing teams.
- Someone who can prioritize competing business needs, manage risk proactively, and drive execution in a fast-paced environment.
- A genuine customer focus and the ability to build trusted, long-term sponsor relationships.
- Passion for operational excellence, innovation, and continuous improvement.

Ready to lead this work? If you are passionate about Clinical Data Management and shaping how clinical research gets delivered, we would love to hear from you. Apply now or share this opportunity with your network.

[email protected]@acrosian.com

📌 Associate Director, Clinical Database Programming (Bengaluru)
🏢 Acrosian
📍 Bengaluru