Clinical Research Specialist

2 weeks ago

Pune, India NOCCARC Full time

****If interested then kindly apply on below link****

About Role: As a Clinical Research Specialist at Noccarc, you will be the in-house doctor who brings the ICU to our R&D floor. You will shape next-generation critical care devices by defining clinical requirements, guiding product development, driving validation and trials, benchmarking against global standards, and leading medical writing and research that advance both our products and the field of critical care.

To know more about Noccarc visit:

Noccarc office video:

Role: Clinical Research Specialist

Location: Pune (5 days WFO)

Reporting To: CTO

Mandatory Requirement: MBBS with 2+ years of ICU

Key Responsibilities:

(A) Product Requirements & Definition

  • Act as the clinical representative within the product team, bringing the perspective of ICU doctors and critical care specialists.
  • Translate customer pain points and real-world ICU/OT scenarios into actionable requirements for engineering and product teams.
  • Define clinical requirements, features, specifications, and performance parameters for critical care medical devices.
  • Participate in risk assessment and hazard analysis from a clinical perspective.
  • Provide continuous clinical feedback during design reviews, prototyping, and testing phases.
  • Support decision-making on trade-offs between usability, clinical performance, and technical feasibility.

(B) Product Testing & Validation

  • Design and coordinate ex-vivo, simulation, and clinical validation studies.
  • Manage clinical validation/ trials, including protocol design, site selection, investigator coordination, and patient studies.
  • Conduct comparative benchmarking of Noccarc devices with competitor products on performance, usability, and clinical outcomes.
  • Prepare and maintain Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and PMCF documents in compliance with EU MDR and other standards.
  • Ensure validation data is scientifically robust and supports regulatory submissions.

(C) Medical Writing & Research Publications

  • Author scientific papers, whitepapers, abstracts, and conference presentations in collaboration with hospitals and research partners.
  • Write clinical manuals, usage guides, and training content for customers and internal teams.
  • Contribute clinical documentation for regulatory submissions.

Requirements:

(A) Education

  • MBBS degree (mandatory).
  • Postgraduate degree in Critical Care, Anesthesiology, Pulmonology, or equivalent preferred.

(B) Experience

  • 2+ years of ICU clinical experience in a reputed hospital (Mandatory)
  • Prior exposure to clinical research, medical devices, is a plus.
  • Experience in clinical trials, medical writing, or regulatory documentation (CER, CEP, PMCF) preferred.

(C) Skills

  • Strong understanding of human physiology, respiratory therapy, and critical care workflows.
  • Proficiency in interpreting clinical literature and writing scientific documents.
  • Ability to define and evaluate product performance in real-world ICU settings.
  • Strong communication skills with ability to influence both clinical and engineering teams.

Why Join Us?

  • Work directly with the founders and R&D leads
  • High ownership, fast learning curve, and direct impact on product outcomes
  • ESOPs for high performers

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