Clinical Scientist - Advanced Clinical : Job Details

The Opportunity:

The Associate Clinical Scientist will contribute to the scientific, clinical, and operational scope of assigned study protocols. This role will work with the cross-functional teams and under the supervision of a senior-level or higher clinical scientist for the design, execution, and monitoring of 1-2 clinical studies, and be responsible for discrete tasks regarding data review, interpretation, and communication to both internal and external stakeholders. Oncology and/or early-stage development experience is preferred.

The Associate Clinical Scientist will be responsible for specific assigned tasks such as:

• Data validation: Checking data against predefined criteria and validation rules to identify discrepancies, errors, and missing values.
• Data reconciliation: Comparing data across different sources (eg, CRFs, lab data, eligibility packets) to ensure consistency and accuracy.
• Query management: Generating and resolving queries to clarify or correct data discrepancies.
• Data standardization: Ensuring data are formatted consistently according to protocol specifications and regulatory standards (eg, CDISC, SDTM).
• Audit trains and documentation: Maintain detailed records of data changes and justifications, ensuring traceability and GCP compliance.
• Contribute to the development of program-level documents, including but not limited to clinical protocols, investigators brochure, clinical study reports, abstracts and manuscripts, presentations, and various other internal and external documents and communications as needed.
• Prepare and/or conduct quality control checks of summaries of clinical data to internal and external stakeholders.
• Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety.
• Interact with internal and external stakeholders (investigators, study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalation.
• Conduct literature reviews as needed.
• Travel: Up to 20%.

Required Experience, Skills, and Education:

• Masters 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 ability 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 Microsoft Excel and Word), Electronic Data Capture, and other custom web-based software.
• Excellent written and verbal communication skills.