Doctor

5 days ago

Lucknow, India MEDICLIN CLINICAL SERVICES PVT LTD Full time

**Key Responsibilities**
- Ensure standardization of procedures for CPU operations as per in
- house SOP's and applicableregulatory guidelines.
- Responsible for preparation and/or review of relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements.
- Preparation, review, provide scientific inputs in the development of Protocol’s/ICD /CSR/FORBE and other study documents.
- Coordinating with EC for approval of study documents.
- Co-ordinating with designated pharmacist for receipt, verification, dispensing, retention of IP’s and ensure timely and prompt intimation to the sponsor for any discrepancies.
- Co-ordination with BD/project management/sponsor for proper slotting of Clinical Studies.
- Ensure the readiness of facilities with respect to administrative aspects (personnel, equipment’s, machines etc.), ICU along with emergency drugs, availability of an ambulance during conduct of study.
- AE’s/SAE’s: Identification of AEs/SAEs and prompt management & timely notification of SAE to the EC/ sponsor/regulatory.
- Review of clinical study reports, REMS, abbreviated clinical study reports, e CTD (Electronic Common Technical Document) Module
- 2 & Module
- 5 as per ICH GCP clinical and non-clinical overviews, safety reports, Investigator's Brochure (IB), periodic safety update reports as per applicable guidelines, and client specifications.
- Efficient team management, encourage communication, transparency and alignment of thought processes and actions.
- Ensure proper training on SOP’s/guidelines/protocol training.
- To respond study related all queries raised by auditors/monitors/regulatory authorities/IEC in timely manner.
- Implementation of safety management system requirements at work places along with maintenance of zero injury & fire incident.

**Salary**: ₹55,000.00 - ₹65,000.00 per month

**Benefits**:

- Health insurance
- Leave encashment
- Provident Fund

Schedule:

- Morning shift

Ability to commute/relocate:

- Lucknow, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Doctorate (preferred)

**Experience**:

- MBBS (preferred)
- total work (preferred)
- Health insurance

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