Clinical Database Programmer II

Posted 4 Hours Ago
Be an Early Applicant
2 Locations
In-Office
Mid level
Pharmaceutical
The Role
Design, build, and maintain clinical trial databases (EDC/CDMS); program and validate edit checks; annotate eCRFs; integrate third‑party systems; document per SOPs/ICH‑GCP/21 CFR Part 11; support project technical queries and contribute to standards and process improvements.
Summary Generated by Built In

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 Clinical Database Programmer II provides technical expertise for the conduct of clinical trials and works with minimal supervision to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies.

General areas of responsibility also include: eCRF design, edit check programming, edit check validation and integration of third-party systems with the EDC databases. 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:

Setup Database

  • 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.

  • 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 eCRFs following SOPs and internal process guidelines.

Support Project

  • Assist in providing technical solutions to internal or external/client enquiries. 

  • Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting and other programming language usage and processes within the GDO area.

  • Ensure adherence to service level 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. 

Skills:

  • Excellent communication skills, with fluency in written and spoken English.

  • Demonstrated ability to learn new systems and function in an evolving technical environment.

  • Attention to detail.

  • Ability to work together with a team (including international teams as required) as well as independently.

  • Demonstrate strong organizational skills, the ability to manage competing priorities, and flexibility in adapting to change.

  • Business/Operational skills that include customer focus, commitment to quality management and problem solving.

  • Work effectively in a quality-focused environment.

Knowledge and Experience

  • 3 to 5 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.  
     

Education:

  • Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.

Skills Required

  • 3 to 5 years of experience in Clinical Data Programming
  • Experience in at least one programming environment (SAS, CDMS, EDC, SQL, VB, Java)
  • Knowledge of SOPs, Work Instructions, System Life Cycle methodologies, ICH-GCP and 21 CFR Part 11 with practical application
  • Bachelor's degree in a relevant science discipline or equivalent work experience
  • Excellent written and spoken English communication skills
  • Attention to detail, strong organizational skills, ability to manage priorities and work independently and in teams
  • Customer focus, commitment to quality management and problem solving
  • Ability to learn new systems and function in an evolving technical environment

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.

  • 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.
  • 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.
  • 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.

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The Company
HQ: Raleigh, NC
20,524 Employees

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.

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