Senior Clinical Data Engineer

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Lead and execute Data Receipt Agreements with vendors through collaborative efforts across various functions.

• Program and set up import procedures for data ingestion utilizing SAS, Workbench, or other technologies.

• Design and implement reconciliation checks to ensure the precision of data transfer.

• Program offline listings and tailor reports to deliver actionable insights.

• Consolidate data from multiple sources and manage external data efficiently.

• Address missing values, raw data files, data structures, and operations involving SAS datasets.

• Review and assess data outputs to provide insights to study teams and clients.

• Ensure first-time quality in all deliverables.

• Manage electronic data timelines and collaborate with project teams.

• Lead programming teams to achieve successful study completion within established timelines and budget.

• Deploy and oversee data management technologies (Workbench, SAS, R, etc.).

• Maintain thorough study documentation in line with SOPs, guidelines, and work instructions.

• Ensure traceability and compliance with regulatory requirements across all activities.

• Document deviations and communicate these to project teams.

• Engage in the development of standards through tools (SAS macros, libraries, processes).

• Create and implement project-specific tools and templates.

• Enhance efficiencies through standardized project structures and naming conventions.

• Support business development initiatives and participate in bid defense meetings.

⛳️ Requirements

• Bachelor's degree (or equivalent) in a relevant scientific discipline.

• Proficiency in at least one programming language (SQL, SAS, or R).

• Strong analytical and problem-solving capabilities.

• Ability to make informed decisions in uncertain situations.

• Understanding of Clinical Research Standards (CRS) concepts.

• Capability for root cause analysis.

• Proficiency in at least one of the following: SQL, SAS, or R.

• Knowledge of SOPs, guidelines, work instructions, system life cycle methodologies, ICH-GCP, and applicable regulations (e.g., 21 CFR Part 11).

• Demonstrated practical application of regulatory and compliance frameworks.

• Experience with at least two systems used for aggregating data in clinical trials (e.g., SAS, Workbench, Elluminate).

• Strong background in the clinical research industry or a related field.

🏝️ Benefits

• N/A