Clinical Development Scientist, Computed Tomography

About the role

The Clinical Development Scientist for our Computed Tomography business analyzes clinical studies and protocols to ensure regulatory compliance, data integrity, and strategic alignment while developing high-quality CERs, CSRs, regulatory submissions, and scientific publications. The role also advances clinical development and market access strategies by generating evidence-based insights, cultivating KOL relationships, and supporting innovative clinical study designs.

Responsibilities

• Collect, appraise and analyze clinical data pertaining to a medical device.
• Write documentation, such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports, supporting regulatory submission.
• Collaborate with internal (project owners, regulatory, study managers, statisticians, business leaders, post-market surveillance, risk management, etc.) and external (clinical consultants, subject matter experts, regulatory agencies) partners to ensure comprehensive analysis of clinical evidence.
• Ensure appropriate interpretation and dissemination of all evidence generated, including writing Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Reports, and supporting the timely publication of study results.
• Create procedures and workflows related to the Clinical Development department.

Requirements

• Acquired 2+ years of experience in Clinical Affairs, Clinical Research, or a similar role within the Medical Device, Pharmaceutical, or Healthcare industry, with a proven track record of delivering clinical results on time, within budget, and in compliance with SOPs and regulatory requirements.
• A strong understanding of EU Medical Device Regulations, Good Clinical Practice (GCP), and ICH guidelines; experience with clinical investigation design, biostatistics, research methodologies, medical and scientific literature databases, and medical writing.
• Experience applying statistical methods to clinical data and proficiency with statistical software are preferred.
• An MSc, Ph.D., M.D., or Pharm.D. in Biomedical Sciences, Life Sciences, Public Health, or a related healthcare discipline.
• Experience authoring MEDDEV 2.7.1 Rev. 4 and MDR-compliant Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) documentation is a strong plus.

Qualifications

• Detail-oriented and highly organized professional with excellent analytical, communication, and project management skills.
• Effectively collaborate with cross-functional and global teams, manage multiple priorities in a fast-paced environment, and communicate fluently in English; additional language proficiency is an advantage.

Skills

• Strong understanding of EU Medical Device Regulations, Good Clinical Practice (GCP), and ICH guidelines.
• Experience with clinical investigation design, biostatistics, research methodologies, medical and scientific literature databases, and medical writing.
• Proficiency with statistical software.

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Orange, OH is $102,000 to $162,000. The pay range for this position in Malvern, PA is $107,000 to $170,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Schedule

This is an office-based role.