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Senior Clinical Data Programmer

2+ 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: The Clinical Data Programmer-II (CDP-II) at Novotech will play a key role within the Data Management department. This position is responsible for executing programming activities on clinical trial projects, ensuring adherence to 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.
  • Hands-on experience with Custom Functions/C# is preferred.

Responsibilities:

  • Clinical Database Management: Design and implement clinical databases, program data review listings, and handle data reconciliation, ensuring compliance with SOPs and ICH-GCP.
  • Programming and Testing: Develop, program, test, and maintain clinical trial databases across various applications according to Novotech standards.
  • External Data Integration: Manage external data loads (e.g., labs, ECGs) and liaise with vendors to establish data transfer specifications.
  • Quality Assurance: Ensure all programming activities adhere to standard operating procedures and good programming practices.
  • EDC Application Experience: Develop, validate, and maintain clinical trials in different EDC applications.
  • CRF Annotation: Annotate Case Report Forms (CRFs) according to CDISC or sponsor-specific guidelines, including appropriate metadata for case report tabulation (CRT) datasets.

About Us: Novotech operates across 11 regions with partnerships at key medical institutions. As a leading Asia-Pacific biotech specialist CRO, Novotech offers 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 is ISO 27001 certified, ensuring the highest 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 from Phase I to Phase IV and bioequivalence studies, Novotech supports biopharmaceutical clients conducting trials in Asia and globally. As of September 30, 2021, Novotech had over 2,750 FTEs across Asia-Pacific, the United States, and the UK.

Why Join Us: Novotech is committed to creating a great workplace with a focus on gender equality and inclusivity. We offer flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities. We encourage applications from individuals who are 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 commit to responding to every application. We look forward to connecting with you about your application.

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