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.
The Principal Clinical Database Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Clinical Database Programmer can fill the Database Primary (late phase) or Technical Lead role on projects; liaise with sponsors, Data Management Leads and other functional areas as required. General areas of responsibility also include eCRF design, edit check programming and integration of third-party systems with the EDC databases. Further, the Principal Clinical Database Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets. All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
Key Accountabilities:
Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems
Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper-based and/or web-based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
Accountable for first time quality on all deliverables.
Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines.
Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to.
Coordinate and lead a programming team to successful completion of a study within given timelines and budget.
Actively assume activities on a project as required.
Monitor project resourcing and identify changes in scope.
Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.
Interact with Sponsors and Data Management Leaders as the key contact regarding programming related issues.
Provide technical support and advice to the internal team.
Ability to lead and support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies on multiple projects simultaneously.
Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).
Support Projects & Technologies
Assist in providing technical solutions to internal or external/client enquiries.
Support to build or integrate systems within the GDO Area. Execute other programming languages and processes within the GDO area. (e.g. Clinical Trial Management System, Safety Systems, Coding Systems).
Ensure adherence to service levels agreements regarding the turnaround time from the point when specifications are finalized.
Documentation
Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
Maintain technical documentation that is applicable to the Clinical Database.
Support Initiatives
Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.
Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiency.
Lead or drive global initiatives (related to processes or new tools/technologies).
Act as a mentor and/or SME
Provide, create and implement relevant training for staff. Provide mentorship to staff and project teams as appropriate.
Assist project teams in the resolution of problems encountered in the conduct of their daily work.
Assist in providing technical solutions to internal or external client enquiries.
Maintain and expand local and international regulatory knowledge within the clinical industry.
Support Business Development
Prepare for and participate in Bid defense meetings.
Independently support ideas around technology and database setup to help drive winning new business.
Account Leadership
Point of contact for clients and within Parexel for database programming specific matters.
Create and maintain partnership training standards in applicable system (MDR, RAVE).
Communicate updates to standards with database programming team. Coordinate updates as required.
Skills:
Excellent ability to lead and collaborate with global teams and work independently. Motivate/guide virtual teams across multiple time zones and cultures to work effectively.
Strong negotiation skills and ability to influence them to achieve mutually beneficial results.
Excellent interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach.
Learning ability and knowledge sharing approach; swift understanding of technologies and new processes.
A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments.
Customer focus on interacting professionally and respectfully within Parexel and all external colleagues to build rapport and trust.
Commitment to first time quality, including a methodical and accurate approach to work activities.
Proficient presentation skills.
Time management and prioritization skills to meet objectives and timelines.
Highly developed problem-solving skills including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses.
Ownership and accountability relative to Key Accountabilities in Job Description.
Good business awareness/business development skills (including financial awareness).
Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
Demonstrate commitment to refine quality processes.
Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement.
Excellent analytical skills.
Tenacity to work in an innovative environment.
Ability to travel as required.
Written and oral fluency in English.
Knowledge and Experience:
8+ Years of experience in Clinical Data Programming.
Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java).
Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
Strong experience working with at least two systems used within the Clinical Trial process (e.g. SAS, CDMS, EDC (Inform, RAVE, DataLabs, Medrio, Veeva), CTMS, Medical Safety Reporting) is desirable. Build Certified in at least one system, if available.
Strong experience in clinical research industry or similar field is required.
Knowledge of Software Development Life Cycle (SDLC) methodologies. Knowledge of GCP, 21 CFR Part 11 and other relevant ICH/regulatory guidelines.
Team and Project leadership experience required.
Education:
Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.
Skills Required
- 8+ years of experience in Clinical Data Programming
- Experience in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java)
- Knowledge of SOPs/Guidelines/Work Instructions, System Life Cycle methodologies, ICH-GCP and 21 CFR Part 11
- Team and project leadership experience
- Written and oral fluency in English
- Ability to travel as required
- Strong experience with at least two clinical systems (e.g., Inform, RAVE, DataLabs, Medrio, Veeva, CTMS, Medical Safety Reporting)
- Build certified in at least one system (if available)
- Bachelor's degree in a relevant science discipline or equivalent work experience
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
