Clinical Scientist

Responsibilities

Develop clinical data strategies and independently design assigned clinical studies in collaboration with cross-functional teams (C1 study phase through handoff)

Develop and maintain relationships with physician experts (e.g., National Principal Investigators, Steering Committee members) to meet clinical program objectives

Lead efforts for the analysis, interpretation, presentation, and reporting of clinical and imaging data to relevant stakeholders

Author and own the clinical data content within regulatory submissions (IDEs, PMAs, 510(k)s, CE Mark submissions); partner with Regulatory Affairs on submission planning and data response strategies

Coordinate the presentation of information to DSMB in accordance with the DSMB Charter, including data summaries, patient summaries, study notifications, and meeting attendance

For studies with an imaging component: coordinate receipt, review, and core laboratory selection, training, and management for independent imaging review

Develop and execute publication and presentation plans for assigned studies in collaboration with relevant stakeholders

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; 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

Preferred

advanced degree (Master's or PhD)

Experience with regulatory submissions and clinical evidence documentation

Benefits

Remote work arrangement

Glassdoor

3.5

Minimally invasive medical device company for healthcare systems.

Bloomington, Indiana, USA

http://www.cookmedical.com

Late Stage

Leadership Team

Gayle Cook

Co-founder

Barry Slowey

Vice President - Chief Sustainability Officer

Recent News

startupresearcher.com

Zenflow Raises $52 Million Series D and Partners with Cook Medical

2026-10-07

Medical Device Network

Zenflow raises $52m for BPH implant and inks US distribution pact with Cook Medical

EIN Presswire

In-Vitro Fertilization Market to reach USD 55.94 Billion by 2035 at 7.70% CAGR

2026-09-08

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Qualifications

Bachelor's degree in Life Sciences, Engineering, or a closely related field

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

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

This role requires 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

Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Advanced degree (Master's or PhD)

Experience with regulatory submissions and clinical evidence documentation

Required skills

Clinical Study Design, Clinical Research, Clinical Data Analysis, Clinical Data Strategy, Clinical and Imaging Data Interpretation, Clinical Practice (GCP), ISO 14155, FDA Regulatory Requirements, International Regulatory Requirements, Regulatory Submissions, Clinical Evidence Documentation, Artificial Intelligence (AI) and Data Concepts

Preferred skills

advanced degree (Master's or PhD)

Experience

3+ years