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SThree

Clinical Data Manager

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Job Description

Clinical Data Managers play a critical role in ensuring the integrity, accuracy and regulatory compliance of data collected across clinical trials. This is an opportunity to register your interest in future Clinical Data Manager positions where you could help advance life-changing therapies from development through to patient access. Please note the content of this advert does not represent a live vacancy. About the opportunity Roles of this type sit at the intersection of clinical operations, regulatory affairs and data governance. You could work within a collaborative team environment supporting the design, collection, validation and management of clinical trial data under Good Clinical Practice (GCP) standards and FDA regulations. The work typically involves coordinating across clinical sites, sponsors and contract research organizations to maintain data quality while meeting regulatory timelines and protocol requirements. Typical role overview

Location:
Chicago, Illinois, USA Type:

Permanent

•

Full-time Salary:

$110,000 - $170,000 per annum, dependent on experience

Domain:

Clinical trial data management

• Life sciences

• Healthcare compliance What you would do Typical responsibilities could include: Managing the end-to-end data lifecycle for assigned clinical trials, from protocol initiation through database lock Building and maintaining clinical trial databases using industry-standard Electronic Data Capture (EDC) systems Developing and executing data management plans, edit checks, and validation rules aligned with protocol requirements Coordinating with clinical research coordinators and site personnel to resolve data queries and ensure protocol compliance Performing data quality reviews, gap analyses and reconciliation to identify discrepancies and recommend corrective actions Supporting regulatory submissions by preparing data narratives, datasets and audit trails for FDA and other governing bodies Maintaining detailed documentation of all data management activities for regulatory inspection readiness Collaborating with biostatisticians, medical monitors and quality assurance teams to ensure data integrity throughout the trial lifecycle What you could bring Most roles of this type require the following: Must-have 2-5 years of clinical data management experience in a pharmaceutical, biotechnology, medical device or contract research organization setting Strong knowledge of GCP guidelines, FDA regulations and 21 CFR Part 11 compliance requirements Proficiency with Electronic Data Capture (EDC) systems and data management software (e.g., Medidata Rave, Oracle Clinical, SAP) Working knowledge of clinical trial protocols, case report forms (CRFs) and data standards (e.g., CDISC, SDTM) Excellent attention to detail with demonstrated ability to identify and resolve data quality issues Strong written and verbal communication skills, particularly when coordinating across multiple stakeholders Bachelor's degree in Life Sciences, Data Science, pharmacy, nursing, or a related field Nice-to-have SOCRA GCP or ACRP certification Experience with multiple therapeutic areas or trial phases Knowledge of patient safety reporting and adverse event management Exposure to remote or decentralized clinical trial models What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Direct involvement in advancing clinical therapies and supporting patient safety through rigorous data governance Exposure to diverse therapeutic areas and phases of clinical development Structured professional development, potential progression toward senior data management or clinical operations leadership roles Ongoing training in emerging data standards, regulatory frameworks and trial technologies Comprehensive benefits including medical, dental and vision coverage, paid time off, 401(k) retirement planning, flexible work arrangements and professional development support About Specialist Staffing Group We are a leading provider of specialized staffing and recruitment solutions within life sciences, healthcare and clinical research. Our mission is to connect talented professionals with meaningful roles that advance patient outcomes and accelerate the development of innovative therapies. We work closely with sponsors, CROs and healthcare organizations to build teams that drive excellence in clinical trial execution and data integrity. 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. Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Professional Development
  • Health Insurance