Senior Clinical Data Engineer

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

📋 Description

• Oversee the design, execution, and administration of Data Receipt Agreements with external vendors.

• Collaborate with cross-functional teams to set up data transfer protocols.

• Program and implement data import processes utilizing SAS, SQL, R, Workbench, or other relevant technologies.

• Create and carry out reconciliation checks and validation procedures.

• Design and develop offline listings and custom reports.

• Collect and manage data from various sources, addressing missing values, raw data files, and intricate data structures.

• Analyze data outputs to detect patterns, anomalies, and areas for enhancement.

• Ensure first-time quality and adherence to SOPs, regulatory standards, ICH-GCP, and 21 CFR Part 11.

• Lead programming teams to deliver projects within set timelines and budgets.

• Monitor resource allocation and manage changes in project scope.

• Oversee the deployment and optimization of data management technologies.

• Create and maintain technical documentation, data standards, and quality assurance processes.

• Mentor team members and project teams effectively.

• Engage in bid defense meetings and contribute to business development initiatives.

⛳️ Requirements

• Bachelor's degree in a relevant scientific field or equivalent professional experience.

• A minimum of 5+ years of experience in clinical research, data management, or a related discipline.

• Advanced proficiency in at least one programming language: SAS, SQL, or R.

• Proven expertise in data manipulation and analysis.

• Practical experience with at least two clinical data management systems, including SAS, Workbench, or Elluminate.

• Comprehensive knowledge of ICH-GCP, regulatory standards, SOPs, system life cycle methodologies, and 21 CFR Part 11.

• Demonstrated leadership experience in mentoring team members and managing technical projects.

• Strong leadership and mentoring skills.

• Excellent analytical and strategic thinking abilities.

• Outstanding written and verbal communication skills in English.

• Capability to present complex technical concepts clearly to varied audiences.

• Experience in clinical research or regulated settings.

• Ability to work with multiple data management systems and adapt to changing technical environments.

🏝️ Benefits

• Opportunities for continuous learning.

• Career advancement paths and skill development across clinical research, data engineering, and regulatory science.