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Clinical Data Programmer Ii

5+ years
Not Disclosed
10 Sept. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Position Overview: As a Clinical Data Programmer-II (CDP-II) at Novotech, you will be an integral part of our Data Management department. In this role, you will handle programming activities for clinical trial projects and ensure compliance with Good Clinical Data Management Practices (GCDMP).

Minimum Qualifications & Experience:

  • Bachelor's degree in Information Science, Life Sciences, or a related field.
  • At least two years of experience in a similar role within a CRO or pharmaceutical company.
  • Preferably experienced with Custom Functions/C#.

Key Responsibilities:

  • Programming Activities: Design, implement, and maintain clinical databases, program data review listings, and manage data reconciliation. Ensure adherence to quality standards, SOPs, and ICH-GCP guidelines.
  • Database Management: Develop, test, and maintain clinical trial databases across various clinical trial applications, following Novotech standards.
  • External Data Integration: Perform external data loads (e.g., labs, ECGs) as required. Liaise with vendors to establish data transfer specifications and standards.
  • Quality Assurance: Ensure all programming activities and processes comply with standard operating procedures and good programming practices.
  • EDC Applications: Develop, validate, and maintain clinical trials within different EDC applications.
  • CRF Annotation: Annotate Case Report Forms (CRFs) in accordance with CDISC guidelines or sponsor-specific requirements, including appropriate metadata for case report tabulation (CRT) datasets.

About Novotech: Novotech operates across 11 regions with partnerships at key medical institutions. As a leading Asia-Pacific biotech specialist CRO, Novotech provides a comprehensive range of clinical development services across all trial phases and therapeutic areas, including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, and report writing to ICH requirements. Novotech holds ISO 27001 certification, demonstrating our commitment to high IT security and quality standards for patients and biotechnology companies.

About the Team: Novotech, with its operating brands Novotech and PPC, is renowned for its expertise in clinical trials and biotech. With experience in over 3,700 clinical projects, including Phase I to Phase IV trials and bioequivalence studies, Novotech supports biopharmaceutical clients conducting trials in Asia and globally. As of September 30, 2021, Novotech employed over 2,750 FTEs across Asia-Pacific, the United States, and the UK.

Why Join Us: Novotech is committed to being an employer of choice for gender equality and providing an inclusive work environment. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities. We encourage applications from individuals passionate about clinical research and biotech, including those who identify as LGBTIQ+, have disabilities, or have caring responsibilities. As a Circle Back Initiative Employer, we pledge to respond to every application and look forward to connecting with you.

For more information and to apply, please visit our website.