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Cook Group
Cook Group
11 – 50 Employees
ConsultingHealthcareLogistics
Cook Group is a family-owned network of entrepreneurial companies rooted in medical devices and healthcare. Based in Indiana with operations spanning a global footprint, the organization works across life sciences, property management, resorts, services, consulting, and logistics. Its businesses are guided by integrity, quality, respect, and transparency, with an emphasis on developing practical solutions for employees, customers, and the communities they serve.
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Clinical Scientist, Medical Device Research — Cook Group (Onsite)

Lead clinical study design, data analysis, and regulatory evidence development for Cook Research’s medical-device programs. Collaborate with physicians, Regulatory Affairs, Engineering, and other cross-functional partners throughout the study lifecycle.

USUnited StatesOn-siteFull-timeMiddleSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Provide scientific direction and subject-matter expertise for assigned clinical studies
  • Create clinical data strategies and independently design studies with cross-functional partners from the C1 phase through handoff
  • Build and sustain working relationships with physician experts, including National Principal Investigators and Steering Committee members
  • Direct the analysis, interpretation, presentation, and reporting of clinical and imaging data
  • Write and manage clinical data content for regulatory submissions, including IDEs, PMAs, 510(k)s, and CE Mark submissions
  • Work with Regulatory Affairs to plan submissions and develop data-response strategies
  • Organize DSMB information presentations in line with the DSMB Charter
  • Oversee receipt and review of imaging materials, including independent review setup, core laboratory selection, training, and management
  • Create and carry out plans for clinical publications and presentations
  • Review and contribute to study documentation, including CIPs, IBs, CRF specifications, IC templates, progress reports, and study overview presentations
  • Support Investigator Meetings and Site Initiation Meetings by reviewing and preparing relevant materials
  • Evaluate study data and milestones, then align study strategy with cross-functional stakeholders
  • Keep communication effective with study teams and stakeholders throughout the clinical study lifecycle
  • May guide Clinical Science Analysts on study-specific data activities

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or a closely related field is required
  • Master’s or doctoral degree preferred
  • At least three years of clinical research experience, including hands-on involvement in clinical study design and data analysis
  • Working knowledge of GCP, ISO 14155, and relevant FDA and international regulatory requirements
  • Experience preparing regulatory submissions and clinical evidence documentation preferred
  • Ability to independently develop clinical data strategies and design clinical studies
  • Strong analytical capability and experience interpreting complex clinical and imaging datasets
  • Working knowledge of regulatory authorities and requirements affecting global clinical studies
  • Excellent written communication skills, including experience authoring clinical study documents and regulatory data sections
  • Strong verbal communication and presentation skills, with the ability to work effectively with physician experts and cross-functional stakeholders
  • Sound independent judgment and awareness of when escalation is appropriate
  • Strong organization and problem-solving skills, with the ability to manage multiple studies and competing priorities
  • Able and willing to travel up to 15% of the time
  • Fluency in artificial intelligence and data concepts, including critically evaluating AI outputs, improving workflows with approved tools, identifying and mitigating bias or inaccuracies, and communicating AI-generated insights clearly and responsibly to peers and managers
  • Legally authorized to work in the United States
  • Employment visa sponsorship is not provided

Benefits

  • Equal opportunity employer
  • Travel of up to 15% of the time

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