Clinical Data Specialists play a crucial role in ensuring the integrity, accuracy and regulatory compliance of data collected during clinical trials. This contract opportunity could involve managing complex datasets, supporting protocol adherence, and maintaining the highest standards of patient safety documentation that ultimately helps bring life-changing therapies to patients. Please note the content of this advert does not represent a live vacancy. About the opportunity This is an opportunity to register your interest in future Clinical Data Specialist contract roles within clinical trial data management. Roles of this type may sit within a collaborative healthcare or pharmaceutical research environment in Chicago, Illinois, working across clinical sites, quality assurance and regulatory teams to ensure data quality and protocol compliance throughout the trial lifecycle. Typical role overview

Location:

Chicago, Illinois, USA Type:

Contract

•

Full-time Rate:

$560 - $800 per day

Domain:

Clinical trials

• data management

• regulatory compliance What you would do Typical responsibilities could include: Managing clinical trial datasets from inception through database lock, ensuring accuracy and completeness Performing data validation, verification and reconciliation against source documents and protocol requirements Documenting data discrepancies and supporting case report form corrections with clinical sites Maintaining detailed audit trails and data management plans in compliance with 21 CFR Part 11 and ICH-GCP guidelines Coordinating with clinical sites, sponsors and regulatory teams to resolve data queries Supporting FDA and other regulatory submissions by ensuring data integrity and traceability Contributing to standard operating procedures and process improvements for data management workflows What you could bring Most roles of this type require the following: Must-have 2-5 years' experience in clinical data management, clinical research or related healthcare data roles Working knowledge of clinical trial protocols, regulatory requirements (FDA, ICH-GCP) and data integrity standards Proficiency with electronic data capture (EDC) systems, databases and data validation tools Strong attention to detail and ability to identify and resolve data discrepancies Experience with source document verification and case report form management Bachelor's degree in Life Sciences, Data Science, or a related field (or equivalent professional experience) Authorization to work in the United States Nice-to-have GCP (Good Clinical Practice) certification or equivalent training Experience with CDISC standards (SDTM, ADaM) Familiarity with statistical analysis software or data visualization tools Experience supporting regulatory submissions What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Opportunity to contribute directly to clinical research that could bring new therapies to patients Exposure to regulated healthcare environments and end-to-end trial data workflows Potential for contract extension or transition to permanent roles, where supported by performance and business needs Professional development through exposure to regulatory standards, compliance best practices and data management methodologies Flexible contract engagement with scope to build experience in clinical data management About Specialist Staffing Group We are a specialist recruitment and staffing partner dedicated to connecting talented professionals with opportunities in life sciences, healthcare, technology and professional services. We work with leading organizations to source, vet and place candidates who can make an immediate impact. Our focus is on understanding both the role requirements and your career aspirations, so we can create meaningful professional matches. How to register interest If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career.