Senior Clinical Data Programmer

2+ years

Not Disclosed

Remote Australia

10 Dec. 5, 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 Title: Senior Clinical Data Programmer (SCDP)
Location: Hybrid (Flexible working hours)
Company: Novotech

About Us:
Novotech is a leading Asia-Pacific biotech specialist Contract Research Organization (CRO) with offices across 11 geographies. We provide clinical development services across all phases of clinical trials, including feasibility assessments, regulatory submissions, data management, safety solutions, and project management. With extensive experience in over 3,700 clinical projects, Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. Novotech is ISO 27001 and ISO 9001 certified, ensuring the highest IT security and quality standards for patients and biotechnology companies worldwide.

Scope of Role:
The Senior Clinical Data Programmer (SCDP) is the primary point of contact for project team members, responsible for addressing and resolving technical and database (DB) development issues. The SCDP will provide leadership and ensure the efficient and accurate delivery of technical solutions across multiple projects. This includes overseeing the work of Clinical Data Programmers (CDPs), ensuring adherence to timelines and quality standards, and troubleshooting any technical issues that arise.

Responsibilities:

Participate in client and project meetings to explain CDP requirements, processes, and throughput times.
Troubleshoot and resolve technical issues, liaising with data management, statistical, and clinical teams to ensure smooth operations.
Coordinate with internal Biometrics teams to address issues impacting the timely delivery of CDP tasks and escalate problems to the Manager and Director of CDP as needed.
Develop advanced programming solutions and custom functions for study database edit checks, configurations, and system requirements.
Perform quality and technical reviews of team members' critical deliverables, including database builds, migrations, locks, decommissioning, and filing critical documentation required in the TMF.
Conduct technical scoping and impact analysis for system changes and database migrations.
Review validation results and implement development fixes, identifying risks and database update requirements proactively.

Minimum Qualifications & Experience:

Graduate in information science, life sciences, or a related field.
Over five years of experience in a Senior Clinical Data Programmer role, preferably in a pharmaceutical company, CRO, or EDC software provider.
Proven experience in supervising and training other programmers.
Extensive programming experience with various EDC tools (e.g., Medidata Rave, Viedoc, Veeva) and associated modules like RTSM and ePRO.

What We Offer:

Hybrid working arrangements with full flexibility in working hours.
An inclusive, diverse work environment with a focus on work-life balance.
Paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities.
We are an equal opportunity employer, supporting individuals from all backgrounds, including those who identify as LGBTIQ+, have disabilities, or have caring responsibilities.

Why Novotech:
Novotech offers a supportive and inclusive work environment, allowing for professional growth and work-life balance. We are passionate about advancing clinical research and biotechnology, providing our team with the flexibility and support they need to succeed.

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