Clinical Specialist

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Direct message the job poster from Integrated Resources, Inc (IRI)

Clinical Development Scientist

DURATION - 11 months

Hybrid (open for MA and MN)

The Ultrasound, Senior Clinical Development Scientist will be responsible for developing, generating, and disseminating clinical and economic evidence to ensure innovation and transformation with best-in-class clinical evidence.

• Provide strategic guidance for clinical and economic evidence related to the end-to-end (E2E) development process from ideation through post-market for Ultrasound products. Collaborate with internal and external stakeholders to develop and lead clinical initiatives, including non-clinical and clinical strategies for new product development and product lifecycle management.
• Ensure quality and timeliness of clinical programs and trials to support regulatory requirements; be agile during design, execution, and interpretation of trial data.
• Work with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; support claims, reimbursement, health economic outcomes, and market access. Prepare and interpret evidence such as CSRs, CERs, abstracts, peer-reviewed manuscripts. Lead or support discussions with regulatory bodies, including clinical investigations and review processes for marketing authorization and line extensions.

• You have 7+ years of experience in clinical research/development/RWE, with expertise in scientific study design, AI algorithm validation, and a strong scientific background.
• You possess knowledge of clinical trial design, registries, quality initiatives, data networks, biostatistics, GCP, FDA regulations, EU-MDR, and product development for medical devices. Skilled in writing clinical documents like study reports, regulatory filings, investigator brochures, and scientific publications.
• You have a medical or scientific degree (MD or PhD). You can perform physical, cognitive, and environmental job requirements with or without accommodations.
• You are self-directed, agile, and work effectively in purposeful environments. You can collaborate cross-functionally, influence decisions, and communicate statistical results clearly.

Show enthusiasm, initiative, and motivation. Demonstrate interest and a positive attitude to stand out.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Contract
• Job function:
  Research
• Industry: Medical Equipment Manufacturing