Clinical Development Scientist
- Redwood City, CA
- $104,000-124,800 per year
- Permanent
- Full-time
- Data validation: Check data against predefined criteria and validation rules to identify discrepancies, errors, and missing values.
- Data reconciliation: Compare data across different sources (e.g., 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 trains 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/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.) to support clinical trial objectives; respond to or triage questions for appropriate escalation.
- Conduct literature reviews as needed.
- Bachelor's degree required; Life Sciences and Advanced Clinical/Science degrees are highly preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
- Minimum 4+ years of experience in clinical development
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
- Proven ability to independently execute medical data review plan(s), secure database(s), and contribute to data interpretation and study reporting (CSR) collaboratively with other clinical development scientists/medical directors/cross-functional groups.
- 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 Microsoft Excel and Word), Electronic Data Capture, Medidata Rave, and other custom web-based software.
- Excellent written and verbal communication skills.