Instagram
youtube
Facebook

Clinical Data Transformation Lead

7+ years
Not Disclosed
10 April 23, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Clinical Data Transformation Lead

Location: Canada, United States (Remote)

About ICON plc: ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence in clinical research.

Responsibilities:

  • Enhance data review and cleaning processes with innovative reports.

  • Create and implement study-specific data validation procedures and reports.

  • Manage connections to varied data sources and ensure efficient scheduling, monitoring, and maintenance on the Clinical Data platform.

  • Detail key data handling requirements for scalable data management methods.

  • Derive study-specific monitoring and validation reports based on clinical protocols and amendments.

  • Engage with Global Development business units such as BDM, Safety, Precision Medicine, Pharmacometrics, and Digital Health to understand data quality, monitoring, and validation needs.

  • Act as the primary point of accountability for interpreting clinical data business needs and translating them into detailed business specifications.

  • Document the clinical product development process, including data sources, methodologies, algorithms, and assumptions.

  • Craft study-specific Data Quality specifications and define key clinical data metrics to uphold data quality and integrity.

  • Prepare study-level reports to support stakeholder activities and ensure effective use of clinical study data.

  • Query clinical data sets, manage data ingestion and delivery specifications, and analyze data inconsistencies.

  • Design requirements for clinical reports and dashboards, presenting findings for key business functions such as Clinical Data Management, Pharmacometrics, and Precision Medicine.

  • Work on preparing Common Data Model mapping and transformations to ensure data usability in the analytical layer.

Qualifications:

  • Bachelor’s degree in Computer Science, Data Science, Statistics, or similar.

  • Over 7 years of experience in clinical data analysis, preferably in the BioPharma sector.

  • Hands-on experience with various clinical datasets such as EDC and non-CRF data.

  • Expertise in Big Data structures, Lakehouse architectures, and data collection techniques.

  • Full understanding of clinical trial processes.

  • Experience with ETL processes and programming languages such as SQL, Python, R.

  • Familiarity with AWS cloud infrastructure (S3, Data Lake).

  • Strong analytical skills with attention to detail.

  • Excellent communication and project management skills.

What ICON can offer you:

  • Competitive salary and benefits focused on well-being and work-life balance.

  • Various annual leave entitlements and health insurance options.

  • Competitive retirement planning offerings to maximize savings.

  • Access to the Global Employee Assistance Programme, TELUS Health, offering 24-hour support.

  • Life assurance and flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, and discounted gym memberships.

At ICON, inclusion & belonging are fundamental to our culture and values. We are committed to providing a workplace free from discrimination and harassment.