Cook Group

Senior Clinical Research Scientist

Cook Group

full-time

Posted on:

Location Type: Remote

Location: Remote • Pennsylvania • 🇺🇸 United States

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Job Level

Senior

About the role

  • Provides technical and scientific guidance for specific project or area of treatment or disease
  • Works with cross functional teams (regulatory, medical affairs, market access, business units, etc.) to evaluate new clinical projects and study strategy
  • Develops clinical study designs and facilitates the transition of projects to clinical operations team
  • Develops central trial documents and contributes to clinical development files
  • Participates in the preparation and review of study-related plans, training materials, and regulatory updates
  • Determines format, evaluation, and interpretation of clinical data
  • Presents clinical trial data internally to relevant stakeholders
  • Leads activities for disclosure of clinical trial data through clinical study reports, abstracts, slide and poster presentations, and manuscripts
  • Key stakeholder in development of clinical publication and communication strategies
  • Develops and maintains relationships with physician experts to ensure proper alignment of clinical development strategy
  • Contributes to risk resolution by escalating and monitoring project risks
  • Maintains effective communication with cross functional teams and stakeholders
  • Performs literature reviews for area of treatment or disease
  • Provides broad medical and scientific support, including training and continuing education, to both internal and field-based teams
  • Participates in medical education and appropriate scientific exchange to enhance product and disease state knowledge
  • Maintains knowledge as to developments and trends in applicable treatment landscape including current treatment strategies, and new therapeutic

Requirements

  • Master's degree in Life Sciences, Health Sciences, or Engineering and 2 years of direct, relevant biotech/pharma industry clinical research experience
  • PhD in Life Sciences, Health Sciences, or Engineering
  • Strong background in data mining, literature searches, and scientific, medical and/or regulatory writing
  • Experience in the conduct and management of clinical studies; Experience in writing study protocols and other technical documents; Working knowledge of regulatory authorities and other regulatory requirements
  • Proficient knowledge of Microsoft Office software, and other general office equipment. Proficiency or comfort level working with material of a highly technical or scientific nature.
Benefits
  • Must maintain company quality and safety standards
  • This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
  • Maintain regular and punctual attendance

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical study designdata miningliterature searchesscientific writingmedical writingregulatory writingclinical trial managementstudy protocol writingrisk resolutionclinical data evaluation
Soft skills
communicationcollaborationstakeholder managementrelationship buildingtrainingproblem-solvingpresentation skillsproject managementcross-functional teamworkscientific exchange
Certifications
Master's degree in Life SciencesMaster's degree in Health SciencesMaster's degree in EngineeringPhD in Life SciencesPhD in Health SciencesPhD in Engineering
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