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Clinical Operation Executive

2 weeks ago

Pune Maharashtra, India Amtech Medidevices Pvt Ltd. Full time

**Key Responsibilities**:
**1. Clinical Trial & Evaluation Management**

Ø Support planning, coordination, and monitoring of clinical trials/studies for medical devices.

Ø Ensure compliance with ISO 13485 requirements.

Ø Assist in the preparation of clinical evaluation reports (CER) as per MEDDEV 2.7/1 Rev. 4 and EU MDR.

Ø Coordinate site selection, investigator meetings, study documentation, and clinical site monitoring.

**2. Documentation & Compliance**

Ø Ensure all clinical documents (protocols, ICFs, case report forms, etc.) are appropriately prepared and maintained.

Ø Maintain Trial Master File (TMF) and other clinical records in line with ISO 13485 QMS.

Ø Assist in writing and maintaining SOPs related to clinical activities.

**3. Regulatory & Quality System Support**

Ø Provide inputs to regulatory submissions with clinical data and documentation.

Ø Work closely with Quality Assurance to ensure that clinical processes meet QMS standards.

Ø Participate in internal and external audits related to clinical operations.

**4. Stakeholder & Site Coordination**

Ø Liaise with investigators, hospitals, CROs, and ethics committees for clinical study approvals and execution.

Ø Coordinate with internal cross-functional teams including R&D, QA/RA, and marketing.

**5. Data & Reporting**

Ø Assist in the collection, verification, and analysis of clinical data.

Ø Prepare study reports, progress summaries, and presentations for internal and external use.

**Required Skills & Qualifications**:
1. Bachelor's or Master’s in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.

2. 2-5 years of experience in clinical research or clinical operations in the medical devices industry.

3. Knowledge of ISO 13485, GCP, and EU MDR/US FDA regulations.

4. Strong documentation and communication skills.

5. Experience working with Clinical Evaluation Reports (CER) is preferred.

6. Detail-oriented, highly organized, and capable of multitasking.

**Preferred Certifications (Optional but Advantageous)**:
a) Certification in Clinical Research (ACRP, SOCRA, or equivalent)

b) ISO 13485 Internal Auditor Certification

Pay: ₹11,660.18 - ₹31,667.69 per month

**Benefits**:

- Health insurance
- Provident Fund

Work Location: In person