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.
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
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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