Clinical Scientist

Cook Group

. Provide scientific leadership and expertise for assigned clinical studies .

Posted 10/7/2026full-timeWest Lafayette • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study design, data analysis, and regulatory submissions, with strong communication skills to engage stakeholders and present findings effectively. Proficient in developing clinical data strategies and managing cross-functional collaborations throughout the study lifecycle.

Highest-signal resume keywords

Clinical Study DesignRegulatory SubmissionsData AnalysisGCP GuidelinesArtificial Intelligence (AI) Concepts

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceData Strategy DevelopmentClinical Data AnalysisRegulatory DocumentationStudy Protocol ReviewStatistical AnalysisImaging Data InterpretationClinical Evidence DocumentationISO 14155 KnowledgeFDA Regulatory Requirements

Soft Skills

Excellent Written CommunicationStrong Verbal CommunicationOrganizational SkillsProblem-Solving SkillsSound Judgment

Industry Keywords

Clinical StudiesCross-Functional TeamsPrincipal InvestigatorsData Safety Monitoring Board (DSMB)Investigator MeetingsSite Initiation Meetings

About the role

Key responsibilities & impact

Provide scientific leadership and expertise for assigned clinical studies
Independently develop clinical data strategies and design assigned clinical studies in collaboration with cross-functional teams from C1 study phase through handoff
Develop and maintain relationships with physician experts, including National Principal Investigators and Steering Committee members
Lead analysis, interpretation, presentation, and reporting of clinical and imaging data
Author and own clinical data content within regulatory submissions, including IDEs, PMAs, 510(k)s, and CE Mark submissions
Partner with Regulatory Affairs on submission planning and data response strategies
Coordinate presentation of information to DSMB in accordance with the DSMB Charter
Coordinate receipt, review, core laboratory selection, training, and management for independent imaging review
Develop and execute publication and presentation plans
Review and provide input on clinical study documents, including CIPs, IBs, CRF specifications, IC templates, progress reports, and study overview presentations
Provide support and review materials for Investigator Meetings and Site Initiation Meetings
Review study data and milestones and coordinate study strategy with cross-functional stakeholders
Maintain effective communication with cross-functional teams and stakeholders across the study lifecycle
May provide guidance to Clinical Science Analyst staff on study-specific data tasks

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Engineering, or a closely related field required
Advanced degree (Master’s or PhD) preferred
Minimum 3 years of clinical research experience, with demonstrated involvement in clinical study design and data analysis
Working knowledge of GCP guidelines, ISO 14155, and applicable FDA and international regulatory requirements
Experience with regulatory submissions and clinical evidence documentation preferred
Proven ability to independently develop clinical data strategies and design clinical studies
Strong analytical skills with demonstrated ability to interpret complex clinical and imaging datasets
Working knowledge of regulatory authorities and requirements that may impact global clinical studies
Excellent written communication skills; experience authoring clinical study documents and regulatory data sections
Strong verbal communication and presentation skills; ability to effectively engage physician experts and cross-functional stakeholders
Sound judgment in independent decision-making with appropriate escalation awareness
Excellent organizational and problem-solving skills; ability to manage multiple concurrent studies and priorities
Willingness and ability to travel up to 15% of the time
Fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers
Legally authorized to be employed in the United States
No employment visa sponsorship provided

Benefits

Comp & perks

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