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Clinical Research Scientist

5 days ago

PayCompetitive
LocationIndiana
Employment typeFull-Time

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  • Job Description

      Req#: 8a7883a89a31ef0c019a5084e75f53de
      Employer Industry: Biopharmaceutical

      Why consider this job opportunity:
      - Competitive salary and industry-competitive compensation
      - Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage
      - 8 weeks of fully paid parental leave for all new parents
      - Flexible work hours and remote work opportunity within the United States
      - 401(k) plan with a 5% employer contribution
      - Generous PTO policy and 11 paid holidays in the US

      What to Expect (Job Responsibilities):
      - Contribute to the development of clinical trial protocols, focusing on data collection strategies and study endpoints
      - Support the development of Clinical Study Reports (CSRs) by providing accurate data summaries and collaborating with medical writing teams
      - Provide scientific oversight for study sites, assisting in protocol adherence and data collection procedures
      - Act as a scientific and clinical disease state expert within project teams, contributing insights for protocol amendments and regulatory submissions
      - Support business development activities by preparing clinical summaries and competitor landscapes

      What is Required (Qualifications):
      - Advanced degree in life sciences, pharmacy, or a related field (e.g., PharmD, PhD, NP, or master's in clinical research)
      - Minimum of 3 years of experience in clinical research or a related field
      - Proficient in tools to evaluate and present data, including Word, Excel, and PowerPoint
      - Solid understanding of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidance
      - Ability to interpret Statistical Analysis Plans (SAPs) and work effectively with statisticians and programmers

      How to Stand Out (Preferred Qualifications):
      - Strong knowledge of data collection and management practices, with demonstrated CRF design experience
      - Familiarity with Clinical Study Report (CSR) templates and regulatory requirements
      - Strong analytical and organizational skills, with attention to detail and commitment to data integrity
      - Ability to work collaboratively across multiple functions and manage complex projects
      - Prior experience in endocrinology and with pediatric populations is a plus

      #Biopharmaceutical #ClinicalResearch #RemoteWork #CareerOpportunity #CompetitiveBenefits

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