Clinical Scientist - Data Strategy & Imaging Lead

Cook Medical Inc.; West Lafayette (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

Cook Medical Inc. seeks a Clinical Scientist to provide scientific leadership for assigned clinical studies and to independently develop data strategies.

You will design studies and lead analysis, interpretation, and reporting of clinical and imaging data in collaboration with Regulatory Affairs, Engineering, and cross-functional teams to advance the clinical evidence program. The role emphasizes developing data strategies, authoring regulatory content, coordinating DSMB activities, and

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• At least 3 years of clinical research experience with study design and data analysis.
• Working knowledge of GCP, ISO 14155, and applicable FDA/regulatory requirements.
• Experience with regulatory submissions.
• Ability to travel up to 15%.
• Excellent written and verbal communication.

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

Skills

Clinical study design

Data analysis

GCP knowledge

Regulatory submissions

Scientific writing

Communication

Travel readiness

AI literacy

Education

Bachelor's degree in Life Sciences/Engineering

Advanced degree (MS/PhD)

Job description

Cook Medical Inc. seeks a Clinical Scientist to provide scientific leadership for assigned clinical studies and to independently develop data strategies.

You will design studies and lead analysis, interpretation, and reporting of clinical and imaging data in collaboration with Regulatory Affairs, Engineering, and cross-functional teams to advance the clinical evidence program. The role emphasizes developing data strategies, authoring regulatory content, coordinating DSMB activities, and