Senior Clinical Scientist

Duties and Responsibilities

• 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, investigator's 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.

Requirements and Qualifications

• Bachelor's degree 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) in a collaborative fashion 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, and other custom web-based software.
• Excellent written and verbal communication skills.
• 4+ years' experience (minimum) in clinical development.

Preferred Qualifications

• A Life Sciences & Advanced Clinical/Science degree is highly preferred (e.g., PharmD, PhD, MSN, MPH, etc.).

Desired Skills and Experience

• Clinical Development, Clinical Research, Clinical Trial Monitoring, Oncology, Early-Stage Drug Development, Clinical Data Review, Medical Data Review Plans, Data Validation, Data Reconciliation, Query Management, Data Standardization, Data Interpretation, Database Lock, Case Report Forms (CRFs), Laboratory Data, Electronic Data Capture (EDC), CDISC, SDTM, Good Clinical Practice (GCP), Regulatory Compliance, Audit Trails, Clinical Protocols, Investigator's Brochures, Clinical Study Reports (CSRs), Study Reporting, Clinical Data Quality Control, Protocol Compliance, Subject Safety, Clinical Trial Documentation, Scientific Writing, Abstracts, Manuscripts, Literature Reviews, Stakeholder Management, Investigator and Study Site Collaboration, Vendor Management, Cross-Functional Collaboration, Microsoft Excel, Microsoft Word, Life Sciences, 4+ Years of Clinical Development Experience