DevJobs

20367 - Clinical Programming Manager

Overview
Skills
  • SQL SQL
  • CDISC
  • SDTM
  • ADaM
  • SAS
Job description:

 

We are seeking expert Full Remote Clinical Programmer Manager (SDTM/CDISC) to lead data quality assurance and regulatory conversion planning for global clinical trials. 

 

Responsibilities

 

  • Provide input for budget planning.Oversee contingent workers and external vendors

  • provide training as needed.Manage programming deliverables at the project level, ensuring quality and on-time delivery

  • Support CDISC-based e-submissions by developing, reviewing, and validating SAS macros and programs

  • Maintain strong knowledge of statistical models used in efficacy data analysis

  • Standardize clinical programming deliverables within projects

  • Develop and extend clinical programming methods to solve complex problems

  • Define Case Report Form (CRF) specifications in compliance with SDTM guidelines and lead cross-functional reviews

  • Define specifications for external (non-CRF) data per Biometrics standards

  • Ensure study databases meet requirements through User Acceptance Testing (UAT)

  • Manage day-to-day clinical and operational data receipt and handling according to study timelines

  • Program SAS/SQL clinical and operational reports and listings

  • Ensure programming processes meet quality standards and regulatory

  • Build and maintain positive partnerships with CROs to ensure high-quality deliverables

  • Act as the primary contact for assigned studies, coordinating with local departments and procedures

  • Support communication, collaboration, and prioritization within the department

Requirements

 

  • Bachelor’s, Master’s, or PhD in Science, Statistics, IT, or related field - Must

  • Minimum 5 years (Bachelor’s) or 4 years (Master’s) experience in pharmaceutical or clinical programming - Must

  • Experience with SDTM, ADaM, and CDISC guidelines preferred

  • Advanced SAS programming skills including development and quality control of integrated analyses

  • Knowledge of drug development regulations across multiple therapeutic areas

  • Strong problem-solving skills and ability to contribute to strategy

  • Excellent communication skills and ability to work effectively in global, multicultural teams

  • Ability to manage multiple projects independently.Detail-oriented with strong knowledge of CDISC standards

 

Profile description:

 

We offer:

 Why should you join us?

 

  • Recognized among Israel's top 100 best places to work for, four years in a row

  • Be part of a company that is a globally recognized leader in Quality Engineering

  • Experience our team spirit, working with real people, and solving real challenges

  • Work with Senior Specialists and Practice Experts

  • Nurture your personal and professional growth through tailored career paths

  • Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers

  • Enjoy unique placement opportunities worldwide

  • We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential

QualiTest Group