As a Clinical Development Scientist, you will work with cross-functional teams and contribute to the execution and monitoring of 1-3 clinical studies, and be responsible for discrete tasks primarily regarding data review and interpretation, as well as communicating to both internal and external stakeholders in support of clinical trial objectives. Oncology and early-stage development experience is required for this 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 such as 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 and individual subject safety issues.
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:
4+ years of experience in clinical development; bachelor's degree required
Oncology and early-stage clinical development experience
Thrives in a collaborative team setting and is driven 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 Microsoft Office (Excel and Word), Electronic Data Capture, and other custom web-based software.
Excellent written and verbal communication skills.
Life Sciences and Advanced Clinical/Scientific degrees are highly preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
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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Desired Skills and Experience Clinical Development, Oncology, data validation, data reconciliation, data standardization, CDISC, SDTM, GCP compliance, Excel, Word, Electronic Data Capture