Senior Clinical Database Programmer eCOA

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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 22000 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 moving 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 capacity based in the 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 translate protocols assessment schedules and licensed instrument requirements into compliant participant caregiver and clinician facing questionnaires schedules and workflows. You will 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 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. 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

Candidate Profile

Youll 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 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

• Bachelors 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

Benefits and Compensation

• Health Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance

For a complete list of benefits please visit potential base pay range for this role is $110000 to $140000 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.

We offer a comprehensive benefits package to eligible employees which includes paid time off a 401(k) match life insurance health insurance and additional benefit offerings in accordance with the terms of our applicable plans.

If this job doesnt sound like the next step in your career but perhaps you know of someone whod be a perfect fit send them the link to apply!

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.

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.