Clinical Research Associate - Medical Device

Role Summary

Role will be a key contributor to the design, development, and clinical validation of next-generation optics based medical devices. This role requires expertise in medical device clinical validation protocols. We are looking for a female candidate who could thrive in a fast-paced environment and possesses a startup mindset.

Responsibilities

1.Clinical Validation

Design, development and review of clinical validation documents, including protocols, IBs, as per IEC standards in securing approvals from ethics committees.

Managing multicentric clinical trials of a medical device developed for gynecological oncology.

Perform comprehensive statistical analysis and interpretation on clinical data

Direct multi-centric clinical trial processes, including patient recruitment, monitoring, and record maintenance by collaborating with an interdisciplinary team.

Work closely with the Clinical Team to understand user needs, optimize workflow, and participate in clinical site visits for device testing.

Qualifications

Education: Master's degree in Biomedical Engineering, Clinical Engineering, Pharmacy or a related field.

Experience: 0-2 years of experience in R&D within the Medical Device industry.

Proven ability to work independently and collaboratively, lead technical workstreams, and collaborate with cross-functional teams.

Presentation skills

Desirable Skills

Proficiency in conducting scientific clinical research, to contribute to advancements in the field of medical instrumentation

Prior Experience with pilot/pivotal trials or hospital environment

Familiarity with Quality Systems (ISO 13485:2015)

Knowledge of medical device regulatory pathways in India (CDSCO)

Clinical Competence

Continuous Learning