Clinical Database Programmer

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(R).

About the Role

Join our team as a Clinical Database Programmer we are particularly interested in candidates who are available to join immediately. In this role you will be responsible for supporting clinical database programming and ensuring high-quality data delivery for clinical studies.

As a Clinical Database Programmer you will provide technical expertise and strategic leadership in the design implementation and management of electronic data capture (EDC) systems and clinical databases that directly impact the integrity and success of clinical trials. This position plays a key role in ensuring regulatory compliance data accuracy and system optimization while advancing patient safety and research quality. Youll collaborate with cross-functional teams including sponsors data management leaders and clinical operations follow industry-standard processes and regulatory requirements and contribute to study operations from planning through closeout.

Responsibilities include leading EDC system setup and maintenance designing and implementing consistency checks mentoring programming teams and supporting business development initiatives. With diverse teams and continuous learning opportunities the Clinical Database Programmer can explore career paths and expand skills across clinical research positioning yourself as a trusted technical authority in clinical data management.

Key Responsibilities:

• Lead and supervise the design implementation and maintenance of electronic data capture (EDC) and clinical database management systems (CDMS) in standard or CDISC-compliant formats ensuring regulatory compliance and first-time quality on all deliverables
• Create implement and maintain consistency checks and edit checks in standard or CDISC format following internal SOPs and external regulatory requirements including 21 CFR Part 11 and ICH-GCP guidelines
• Provide technical leadership and mentorship to programming teams and project staff including training on eCRF design database procedures and best practices in clinical data management
• Serve as the primary technical contact and liaison with sponsors data management leaders and cross-functional teams regarding database programming issues technical solutions and project timelines
• Manage database lock/unlock procedures and approve database changes in accordance with SOPs ensuring adherence to service level agreements and regulatory requirements
• Maintain comprehensive technical and regulatory documentation for clinical databases including deviation logs and traceability records to ensure compliance and audit readiness
• Support the integration and programming of systems within the Global Data Operations area including CTMS safety systems and coding systems while executing multiple programming languages and processes
• Develop improve and implement project-specific tools and standards that enhance efficiency and optimize clinical trial processes across multiple concurrent projects
• Participate in business development activities including bid defense meetings and technical support for new business opportunities

Youll thrive in this role if you bring:

• Technical expertise in clinical database programming EDC systems and CDMS platforms with a proven track record of delivering high-quality compliant solutions
• Strong leadership and mentoring capabilities with the ability to guide and motivate virtual teams across multiple time zones and cultures
• Excellent communication skills with the ability to translate complex technical concepts for diverse audiences including sponsors regulatory bodies and internal stakeholders
• Deep understanding of regulatory requirements ICH-GCP 21 CFR Part 11 and SDLC methodologies with demonstrated commitment to quality and compliance
• Problem-solving mindset with the ability to make sound decisions in ambiguous situations and conduct root cause analyses
• Flexibility and adaptability with a commitment to continuous learning in an evolving technical environment

Required Qualifications

• 2 to 9 years of experience in clinical data programming
• Proficiency in at least one programming environment (e.g. SAS CDMS EDC SQL VB Java)
• Experience with Custom Function programming will be added advantage
• Strong knowledge of SOPs guidelines work instructions SDLC methodologies ICH-GCP and applicable regulatory requirements including 21 CFR Part 11
• Demonstrated experience in the clinical research industry or similar regulated environment
• Strong communication organization and problem-solving skills with proven ability to work independently and collaboratively

Preferred Qualifications

• Bachelors degree in relevant science discipline or equivalent work experience
• Certification in at least one clinical systems platform (e.g. RAVE Veeva)
• Experience with multiple systems used in clinical trial processes (e.g. CTMS medical safety reporting systems or additional EDC platforms)
• Presentation skills and experience supporting business development activities

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