Senior Clinical Programmer

  • Location

    North Carolina, USA

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    Negotiable

  • Contact:

    Jessica Charles

  • Contact email:

    Jessica.Charles@volt.eu.com

  • Job ref:

    78428-PHARM-JCH_1619598597

  • Published:

    3 maanden geleden

  • Expiry date:

    2021-06-27

  • Startdate:

    01/02/21

My client is a full-service CRO with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the market.



They're looking for Senior Clinical Programmers I or II to join their team. This role will include the design, development and maintenance of clinical databases and other application tools supporting data capture and data processing. Also the Senior Clinical Programmer will lead, manage and support the clinical programming tasks to meet project specifications in compliance with study specific plans, standard operating procedures, industry standards and regulatory requirements.



Responsibilities:

Develop and maintain all clinical programming documentations, including study design specifications, UAT plans, test cases and database configuration settings in support of database set-up and edit checks programming.
Develop and/or review Data Validation Plan
Program electronic edit checks and data listings required for data review and validation process
Review electronic Case Report Form (eCRF) Completion guidelines
Develop SAS programs for metric reporting, data review listings, data import and data export set-up
Lead and support application of Clinical Data Interchange Standards Consortium (CDISC) conventions during database build activities and data warehousing, i.e. CDASH and SDTM modules
Review and adhere to the requirements of study specific data management documents & plans
Lead and coordinates clinical programming activities for assigned studies (including monitoring of project timelines, scope of work, budgets, resourcing needs, escalating potential problems effectively and in a timely manner and alerting management of potential change orders)
Understand validation principles and requirements and consistently develops code in accordance with those requirements
Lead development activities and standardizing clinical programming procedures (e.g. setting up global libraries, standard templates)




Qualifications:

BSc/MSc in Life science, healthcare and/or related field
5-10 years of experience in drug development and/or clinical research
Good knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements
Good understanding of clinical data management through several years of clinical programming experience
Experienced in technical data management practices (developing programs, validation plans, testing, and documentation)
Solid understanding and hands-on experiences of CDISC standards (i.e. CDASH and SDTM models)
Strong programming skills with proficiency in Electronic Data Capture (EDC) systems, data reporting and programming languages such as PL/SQL, SAS and comparable field