Clinical Development Scientist

Clinical Development Scientist

W2 Contract-to-Hire

Location: Redwood City, CA - Onsite Role

Job Summary:

As a Clinical Development Scientist, you will work with cross-functional teams to execute and monitor multiple clinical studies, be responsible for discrete tasks primarily regarding data review and interpretation, and communicate to internal and external stakeholders in support of clinical trial objectives. Oncology and/or early-stage development experience is required.

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 (e.g., CRFs, lab data, 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 records of data changes and justifications, 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.

Requirements and Qualifications:

• Bachelor's degree required; life sciences and an advanced Clinical/Science degree are highly preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
• 4+ years of experience in clinical development
• Oncology and/or early-stage development experience is required.
• 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 including Microsoft Office Excel and Word, Electronic Data Capture, and other custom web-based software.
• Excellent written and verbal communication skills

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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