Associate Clinical Scientist

Industry: Private

Employment Type:- Full Time

Work Hours:-  8 Hours

Locations:- USA

Full Job Description:-

Job Summary:

As an Associate Clinical Scientist, you will work with cross-functional teams and senior-level scientists to design, execute, and monitor multiple clinical studies. You will be responsible for discrete data review, interpretation, and communication tasks to internal and external stakeholders. Oncology and early-stage development experience is highly preferred. You may be required to travel up to 20% of the role.

Duties and Responsibilities:

  • Data validation: Check data against predefined criteria and validation rules to identify discrepancies, errors, and missing values.
  • Data reconciliation: Compare data across different sources, including CRFs, lab data, and eligibility packets, to ensure consistency and accuracy.
  • Query management: Generate and resolve queries to clarify or correct data discrepancies.
  • Data standardization: Ensure data is formatted consistently according to protocol specifications and regulatory standards (e.g., CDISC and SDTM).
  • Audit trails and documentation: Maintain detailed data changes and justification records, ensuring traceability and GCP compliance.
  • Contribute to developing program-level documents, including clinical protocols, investigator's brochure, clinical study reports, abstracts and manuscripts, presentations, and other internal and external documents and communications as needed.
  • Prepare and conduct quality control checks of summaries of clinical data to internal and external stakeholders.
  • Ensure trial implementation follows protocol and analyze information to assess protocol conduct or individual subject safety issues.
  • Interact with internal and external stakeholders, including investigators, study sites, vendors, and committees, to support clinical trial objectives; respond to or triage questions for appropriate escalation.
  • Conduct literature reviews as needed.

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Requirements and Qualifications:

  • Master's degree or higher in a scientific discipline or other relevant advanced degree in a health science field.
  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  • Detail-oriented with the ability to prioritize tasks and function independently as appropriate.
  • Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends.
  • Proficient with software tools (Microsoft Office, including Excel and Word), Electronic Data Capture, and other custom web-based software.
  • Excellent written and verbal communication skills.
  • Able to travel up to 20%.

Desired Skills and Experience

Clinical Development, Oncology, data validation, data reconciliation, query management, data standardization, CDISC, SDTM, cGCP, Excel, Word, Electronic Data Capture, travel

Associate Clinical Scientist

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