Associate Clinical Data Manager

Other

Posted 18 days ago


Job description

Responsibilities:
  • Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs)
  • Support database setup activities including edit check specifications and user acceptance testing (UAT)
  • Review incoming clinical data for completeness, consistency, and accuracy
  • Generate, track, and resolve data queries in collaboration with clinical sites
  • Maintain study documentation and data management files
  • Participate in cross-functional study team meetings and data review discussions
  • Support Serious Adverse Event (SAE) reconciliation and external data reconciliation (e.g., labs, central imaging)
  • Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC)
Requirements:
  • Bachelor's degree in a life science, health science, pharmacy, public health, or related field
  • Strong attention to detail, organizational, and time management skills
  • Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint)
  • Effective written and verbal communication skills
  • Ability to learn and apply technical systems and software (EDC, CTMS, etc.)
  • Familiarity with clinical trial processes and Good Clinical Practice (GCP)
  • Experience with EDC systems (e.g., Medidata Rave, Veeva Vault, Medrio) a plus

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About Katalyst Healthcares & Life Sciences

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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Clinical Data Associate?

A: To succeed as a Clinical Data Associate, key technical skills include proficiency in electronic data capture systems, clinical trial management systems, and data management software, as well as knowledge of Good Clinical Practice (GCP) and regulatory requirements. Soft skills such as strong attention to detail, effective communication, and organizational abilities are also crucial, enabling the associate to accurately collect and manage data, collaborate with cross-functional teams, and meet project deadlines. These strengths support career growth by enabling the associate to take on more complex roles, such as data management or clinical research coordination, and contribute to the success of clinical trials and research studies.

Q: What is the career path for a Clinical Data Associate?

A: A Clinical Data Associate typically starts as an entry-level role, progressing to roles such as Clinical Data Coordinator or Clinical Data Specialist, where they manage and maintain clinical trial data, ensuring accuracy and compliance. As they gain experience, they can move into mid-level roles like Clinical Data Manager or Clinical Data Lead, overseeing data quality and implementing data management strategies. Ultimately, senior roles such as Clinical Data Director or Head of Clinical Data Management may be attainable, where they lead teams and drive data-driven decision-making in pharmaceutical, biotechnology, or medical device companies.



Katalyst Healthcares & Life Sciences job posting for a Associate Clinical Data Manager in Lake Forest, IL with a salary of $30 to $40 Hourly with a map of Lake Forest location.