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Clinical Development Scientist

0-2 years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Development Scientist
Location: Redwood City, CA 94063
Employment Type: Contract
Job Category: Clinical Development and Operations
Job Number: 616589
Is Job Remote?: No
Country: United States


Job Overview

Planet Pharma is seeking a Temp Clinical Development Scientist to contribute to the scientific, clinical, and operational aspects of clinical study protocols. This role will involve working with cross-functional teams to execute and monitor 1-3 clinical studies. The candidate will focus on data review, interpretation, and communication with both internal and external stakeholders to support clinical trial objectives, with a strong emphasis on oncology and early-stage development.

Key Responsibilities

  • Data validation: Ensure data accuracy by checking against predefined criteria and validation rules, identifying discrepancies and missing values.
  • Data reconciliation: Compare data from various sources to ensure consistency and accuracy.
  • Query management: Generate and resolve queries to clarify or correct discrepancies.
  • Data standardization: Ensure data are formatted according to protocol specifications and regulatory standards (e.g., CDISC, SDTM).
  • Audit trails and documentation: Maintain detailed records of data changes and justifications, ensuring traceability and GCP compliance.
  • Contribute to the development of clinical documents (protocols, study reports, abstracts, manuscripts, etc.).
  • Conduct quality control checks of clinical data summaries for internal and external stakeholders.
  • Ensure trial implementation in line with the protocol and assess issues related to protocol conduct or subject safety.
  • Communicate with internal and external stakeholders (investigators, study sites, vendors) to support clinical trial objectives.
  • Conduct literature reviews as needed.

Required Qualifications

  • Bachelor’s degree in a relevant field.
  • Minimum 4 years of experience in clinical development, including expertise in medical data review and study reporting.
  • Strong ability to prioritize tasks and function independently.
  • Detail-oriented with strong organizational skills.
  • Proficient in Microsoft Office (Excel, Word), Electronic Data Capture, and web-based software.
  • Excellent written and verbal communication skills.

Preferred Skills

  • Advanced degree in Life Sciences (e.g., PharmD, PhD, MSN, MPH) is highly preferred.
  • Experience in oncology or early-stage clinical development.

Additional Information

Planet Pharma is an equal opportunity employer, committed to diversity, equity, and inclusion.

 

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