Role Description
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 capacity, based in any location in the continental US.
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. This position plays a key role in study execution, regulatory compliance, and clinical data accuracy. You will:
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Translate protocols, assessment schedules, and licensed instrument requirements into compliant participant, caregiver, and clinician facing questionnaires, schedules, and workflows.
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Collaborate with sponsors and cross-functional teams, follow industry-standard processes, and contribute to eCOA study delivery from design through closeout.
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Configure and test eCOA studies in approved platforms and support their integration with Electronic Data Capture (EDC) systems.
You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through building eCOA studies that generate reliable, high-quality data, supporting multiple projects at once, and sharing technical expertise with project teams.
Key Responsibilities
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Design, set up, maintain, revise, and close out eCOA studies by interpreting protocols, schedules of assessments, eCOA specifications, and licensed instrument requirements.
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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.
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Coordinate the initial eCOA configuration and controlled push to EDC, maintaining alignment among the eCOA configuration, EDC draft, and applicable CRF versions.
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Assess and implement approved protocol amendments, production revisions, translations, and study maintenance changes while protecting data integrity and traceability.
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Perform technical quality control of eCOA configurations against approved specifications and support User Acceptance Testing (UAT), including test evidence, defect triage, and resolution.
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Coordinate deployment readiness and support post-production troubleshooting and controlled implementation of approved corrections.
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Collaborate with Clinical Database Programming, Data Management, eCOA Clinical Data Analysis, COA Science, and Clinical Operations to finalize eCOA requirements and resolve design issues.
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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.
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Serve as a technical contact for sponsors and vendors on eCOA design, specification, testing, and deployment topics, as assigned.
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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.
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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.
Qualifications
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Strengths in questionnaire design, eCOA study configuration, and technical quality control.
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Experience working in clinical research, healthcare, or a regulated environment.
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The ability to collaborate across global, cross-functional teams and communicate technical design decisions clearly to technical and non-technical audiences.
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A patient-focused mindset and strong attention to detail.
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Comfort working with eCOA platforms such as Medidata Designer eCOA, EDC systems such as Medidata Rave, and validated clinical systems.
Requirements
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Bachelor's degree in life sciences, computer science, health informatics, clinical research, or a related discipline.
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Proven experience with eCOA, ePRO, or eDiary.
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Strong clinical research industry experience within a CRO or pharmaceutical setting.
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Experience with EDC systems and an understanding of eCOA-to-EDC configuration dependencies and data flow.
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Knowledge of questionnaire design, schedules, branching logic, reminders, notifications, translations, version management, and participant workflows.
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Knowledge of SOPs, Work Instructions, system life-cycle methodologies, ICH-GCP, 21 CFR Part 11, and other applicable local and international regulatory requirements.
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Experience with technical quality control, UAT, defect management, change control, and validated clinical systems.
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Experience supporting global studies, sponsors, and cross-functional project teams.
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Strong communication, organization, and problem-solving skills, including root-cause analysis, risk identification, and decision-making in ambiguous situations.
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Proficient presentation and system-demonstration skills.
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Written and oral fluency in English.
Preferred Qualifications
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Hands-on experience configuring an eCOA platform such as Medidata Designer eCOA, or comparable study-design technology.
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Experience with Medidata Rave EDC.
Benefits
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Health, Vision & Dental Insurance.
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Tuition Reimbursement.
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Vacation/Holiday/Sick Time.
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Flexible Spending & Health Savings Accounts.
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Work/Life Balance.
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401(k) with Company match.
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Pet Insurance.
Compensation
The potential base pay range for this role is $110,000 to $140,000 USD yearly salary. The actual salary offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.