Principal Clinical Data Engineer

Parexel - King of Prussia, PA

Full-time - Principal

King of Prussia, PA

Professional, Scientific, and Technical Services

About the position

As a Principal Clinical Data Engineer at Parexel International Corporation, you will play a pivotal role in managing projects and technology related to clinical data. Your primary responsibility will be to lead and implement the setup of Data Receipt Agreements with vendors, collaborating with cross-functional teams to ensure seamless data integration. You will be tasked with programming and setting up import procedures to facilitate the ingestion of data using SAS or alternative technologies such as Workbench. Additionally, you will develop reconciliation checks to verify the accurate transfer of data and create offline listings and custom reports to provide valuable insights into external data sources. Your role will also involve aggregating data from various sources, handling missing values, reading raw data files, and creating data structures. You will be responsible for reviewing data outputs to provide insights to study teams and clients, ensuring first-time quality on all deliverables. You will actively manage project timelines, monitor resources, and assist project teams in resolving issues to maintain high-quality standards. As a leader, you will coordinate a programming team to successfully complete studies within specified timelines and budgets, while also managing the deployment of data management technology used for creating offline listings. Documentation is a critical aspect of this role, as you will maintain all supporting documentation for studies in compliance with SOPs, guidelines, and work instructions. You will also participate in the creation of standards and develop project-specific tools to enhance efficiency. As a mentor and subject matter expert, you will provide training and support to staff, assist in problem resolution, and maintain regulatory knowledge within the clinical industry. In addition to your technical responsibilities, you will support business development efforts by preparing for bid defense meetings and contributing ideas around technology and data engineering setups to help secure new business. You will serve as the primary point of contact for clients regarding electronic data matters, ensuring effective communication and collaboration.

Responsibilities

• Lead and implement the setup of Data Receipt Agreements with vendors.
• Program and set up import procedures for data ingestion using SAS or alternative technologies.
• Develop reconciliation checks to ensure accurate data transfer.
• Create offline listings and custom reports for better insights into external data.
• Aggregate data across all sources and handle missing values.
• Read raw data files and create data structures while managing programming errors.
• Review data outputs to provide insights to study teams and clients.
• Ensure first-time quality on all deliverables.
• Negotiate electronic data timelines and ensure adherence to them.
• Monitor project resourcing and identify changes in scope.
• Assist project teams in resolving daily work problems to ensure quality.
• Coordinate and lead a programming team to complete studies within timelines and budget.
• Manage the deployment of DM technology for offline listings.
• Maintain supporting documentation for studies in accordance with SOPs and guidelines.
• Participate in the creation of standards and develop project-specific tools.
• Act as a mentor and provide training to staff and project teams.
• Support business development by preparing for bid defense meetings and contributing ideas.
• Serve as the point of contact for clients regarding electronic data matters.

Requirements

• Proficiency in at least one of the following: SQL, SAS, R.
• Strong experience in the clinical research industry or a similar field.
• Knowledge of SOPs, guidelines, and system life cycle methodologies, including ICHGCP and 21 CFR Part 11.
• Experience working with at least two systems used to aggregate data within the Clinical Trial process.
• Bachelor's degree (or equivalent) in a relevant science discipline or equivalent work experience.
• Team and project leadership experience.

Nice-to-haves

• Excellent negotiation skills and ability to influence outcomes.
• Advanced presentation skills.
• Good business awareness and financial awareness.
• Ability to create and maintain strategies to improve clinical trial efficiency.
• Demonstrated commitment to refining quality processes.