Principal Clinical Database Programmer (eCOA Study Builder)

Principal Clinical Database Programmer (eCOA Study Builder)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose. We move with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

About the Role

We are seeking a Principal Database Programmer (eCOA Study Builder / Designer) specializing in electronic Clinical Outcome Assessment (eCOA) solutions to join our team in a Remote/Hybrid/On-site(Hyderabad or Bengaluru) capacity. As a Principal Database Programmer (eCOA Study Builder / Designer), you will provide technical expertise for the design, configuration, testing, deployment, and maintenance of eCOA solutions used in clinical trials that help advance new treatments for patients. This position plays a key role in study execution, regulatory compliance, and clinical data accuracy. You'll translate protocols, assessment schedules, and licensed instrument requirements into compliant participant, caregiver, and clinician-facing questionnaires, schedules, and workflows, collaborate with sponsors and cross-functional teams, follow industry-standard processes, and contribute to eCOA study delivery from design through closeout. Responsibilities include configuring and testing eCOA studies in approved platforms and supporting their integration with Electronic Data Capture (EDC) systems, with opportunities to deepen your expertise and influence study outcomes.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through translating protocols into compliant eCOA studies, configuring and testing them, and supporting EDC integration. With diverse teams and continuous learning opportunities, the Principal Database Programmer (eCOA Study Builder / Designer) can explore career paths and expand skills across clinical research.

Key Responsibilities

• Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols, schedules of assessments, eCOA specifications, and licensed instrument requirements

• Configure questionnaires, screens, field properties, code lists, schedules, branching logic, rules, reminders, alerts, notifications, and study settings in the approved eCOA platform, applying established naming conventions and build standards

• Coordinate the initial eCOA configuration and controlled push to EDC, maintaining alignment among the eCOA configuration, EDC draft, and applicable CRF versions

• Assess and implement approved protocol amendments, production revisions, translations, and study maintenance changes while protecting data integrity and traceability

• Perform technical quality control of eCOA configurations against approved specifications and support User Acceptance Testing (UAT), including test evidence, defect triage, and resolution

• Coordinate deployment readiness and support post-production troubleshooting and controlled implementation of approved corrections

• Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, and Clinical Operations to finalize eCOA requirements and resolve design issues

• Lead or participate in design and build meetings, communicate configuration status, identify risks and dependencies, and manage scope, timeline, and resourcing changes across multiple projects

• Serve as a technical contact for sponsors and vendors on eCOA design, specification, testing, and deployment topics, as assigned

• Create and maintain eCOA specifications, configuration records, test evidence, and other study artifacts in accordance with SOPs, Work Instructions, ICH-GCP, and applicable regulatory requirements

• Provide role-relevant training, coaching, and technical guidance to project teams and less-experienced study designers, and contribute to standards, reusable libraries, and continuous improvement

You'll thrive in this role if you bring:

• Strengths in questionnaire design, eCOA study configuration, and technical quality control

• Experience working in clinical research, healthcare, or a regulated environment

• The ability to collaborate across global, cross-functional teams and communicate technical design decisions clearly to both technical and non-technical audiences

• A patient-focused mindset and strong attention to detail

• Comfort working with eCOA platforms such as Medidata Designer eCOA, EDC systems such as Medidata Rave, and validated clinical systems

Required Qualifications

• Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related discipline

• Proven experience with eCOA, ePRO, or eDiary

• Strong clinical research industry experience within a CRO or pharmaceutical setting

• Experience with EDC systems and an understanding of eCOA-to-EDC configuration dependencies and data flow

• Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows

• Knowledge of SOPs, Work Instructions, system life-cycle methodologies, ICH-GCP, 21 CFR Part 11, and other applicable local and international regulatory requirements

• Experience with technical quality control, UAT, defect management, change control, and validated clinical systems

• Experience supporting global studies, sponsors, and cross-functional project teams

• Strong communication, organization, and problem-solving skills, including root-cause analysis, risk identification, and decision-making in ambiguous situations

• Proficient presentation and system-demonstration skills

• Written and oral fluency in English

Preferred Qualifications

• Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology

• Experience with Medidata Rave EDC

 

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

Experience Level

Senior Level