Clinical Development Scientist

Clinical Development Scientist

The Temp Clinical Development Scientist will contribute to the scientific, clinical, and operational scope of assigned study protocols. This role will work with the cross-functional teams and report to the a senior-level or higher clinical scientist for 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/or early-stage development experience is required. The Temp Clinical Development Scientist will be responsible for specific assigned tasks such as:

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  Data validation: Checking data against predefined criteria and validation rules to identify discrepancies, errors, and missing values.
  
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  Data reconciliation: Comparing data across different sources (eg, CRFs, lab data, eligibility packets) to ensure consistency and accuracy.
  
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  Query management: Generating and resolving queries to clarify or correct data discrepancies.
  
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  Data standardization: Ensuring data are formatted consistently according to protocol specifications and regulatory standards (eg, CDISC, SDTM).
  
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  Audit trains and documentation: Maintain detailed records of data changes and justifications, ensuring traceability and GCP compliance.
  
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  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.
  
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  Prepare and/or conduct quality control checks of summaries of clinical data to internal and external stakeholders.
  
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  Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety.
  
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  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.
  
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  Conduct literature reviews as needed.
  

Required Skills, Experience, and Education:

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  Bachelor’s degree required.
  
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  Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  
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  Proven ability to independently execute medical data review plan(s), secure database(s), and contribute to data interpretation and study reporting (CSR) in collaborative fashion with other clinical development scientists/medical directors/cross-functional groups.
  
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  Detail-oriented with ability prioritize tasks and function independently as appropriate.
  
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  Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends.
  
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  Proficient with software tools (Microsoft Office including Microsoft Excel and Word), Electronic Data Capture, and other custom web-based software.
  
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  Excellent written and verbal communication skills.
  
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  4+ years’ experience (minimum) in clinical development.
  

Preferred Skills:

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