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1 день назад

Associate Specialist, Clinical Data Management

71 900 - 113 200$
Формат работы
hybrid
Тип работы
fulltime
Английский
b2
Страна
US/Canada
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Associate Specialist, Clinical Data Management (Clinical Programming/Reporting): Designing, building, testing, and documenting clinical data review, reporting, and analytics deliverables across Oracle, Veeva, Power BI, SQL, Databricks, Python, and SAS with an accent on data cleaning, medical review, clinical monitoring, and safety reporting. Focus on implementing study-team programming requirements, supporting in-life reports, tracking incidents and change requests, and improving clinical data systems through automation and validation.

Location: Hybrid; primary location in Rahway, New Jersey, United States. Applications are limited to residents of the United States, Canada, and Puerto Rico.

Salary: $71,900–$113,200 per year for the primary location, plus eligibility for an annual bonus and long-term incentive where applicable.

Company

hirify.global develops medicines and conducts clinical research supported by clinical data management, reporting, safety, and regulatory processes.

What you will do

  • Own clinical programming, reporting, and analytics deliverables across Oracle, Veeva, and external clinical-study data.
  • Design, build, maintain, test, and document data reviews based on specifications from Global Clinical Data Management, Clinical Research, and Global Safety.
  • Assess the technical feasibility of study-team programming and reporting proposals and implement approved solutions.
  • Support data cleaning, medical review, clinical monitoring, and safety reports for timely and quality study delivery.
  • Provide ongoing support for in-life reports and ensure change requests and incident reports are documented, approved, tracked, and reported.
  • Participate in study-improvement task forces, automation initiatives, new-system testing, training, and mentoring.

Requirements

  • Hold a B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science, or receive the degree no later than spring 2027.
  • Good technical proficiency in clinical data management or reporting systems such as Power BI, SQL/PL SQL, Databricks, Python, SAS, or comparable tools, along with AI-related tools.
  • Knowledge of Microsoft Windows and Office software and exposure to web-based applications.
  • Knowledge of system development lifecycle management and system validation.
  • Understanding of the drug discovery process, FDA regulations, GxP guidelines, and ICH.
  • Ability to build relationships across functional areas, communicate effectively with study teams, and demonstrate customer focus.
  • Strong organizational, multitasking, independent-working, urgency, and problem-solving skills, with the ability and desire to learn new processes and technologies.
  • Travel requirements are 10%; a valid driving license is required.

Nice to have

  • Relevant pharmaceutical skills and experience.

Culture & Benefits

  • Hybrid work arrangement on the first shift.
  • Medical, dental, vision, healthcare, and other insurance benefits for employees and families.
  • Retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
  • Inclusive workplace with equal employment opportunities and collaborative problem-solving across diverse perspectives.
  • No relocation is offered and visa sponsorship is not available.

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