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Clinical Manager

0-2 years
Not Disclosed
10 June 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Sciencee Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Clinical Manager

Experience Required: 0 – 2 years
Job Type: Full Time
Location: Mehsana
Department: Clinical Research Department (CRD)
Function: Clinical Research Physician


Functional Role:

Clinical Investigator / Clinical Research Physician


Reporting To:

[To be filled by organization]


Primary Responsibilities:

1. Protocol, ICF, and CRF Preparation

  • Coordinate with clinical research personnel to prepare study Protocols.

  • Assist in drafting the Informed Consent Form (ICF) and Case Report Form (CRF).

2. Ethics Submission

  • Support investigators in submitting study-related documents (e.g., updates, protocols) to the Independent Ethics Committee.

3. Study Coordination

  • Collaborate with investigators to plan study schedules.

  • Coordinate with the screening team for subject recruitment and screening.

  • Ensure volunteers attending ICF presentations meet protocol requirements.

  • Conduct ICF presentations and assist during subject enrollment.

  • Perform clinical examinations and monitor vital signs throughout the study.

  • Ensure subject safety and report adverse events, drug reactions, or clinical emergencies.

  • Make clinical decisions in the absence of the investigator and consult with them as needed.

  • Guide nursing staff on emergency medicine management and Special Care Room protocols.

  • Provide medical assistance to study subjects and employees.

  • Ensure compliance with the protocol, ICH-GCP guidelines, and in-house SOPs.

  • Coordinate clinical staff during admission, discharge, dosing, and subject monitoring.

  • Maintain and generate study-essential documents.

4. Report Preparation

  • Identify and list protocol/SOP deviations during clinical exams or vitals.

  • Collaborate with the investigator to incorporate findings in the final report.

5. Feasibility Assessment

  • Coordinate with research personnel to assess feasibility of various molecules for study.

6. Other Duties

  • Carry out additional tasks as assigned by the reporting authority.


Prepared By (Reporting Manager):

Name: [To be filled]
Designation: [To be filled]
Signature: ____________
Date: ____________


Reviewed By (Department Head):

Name: [To be filled]
Designation: [To be filled]
Signature: ____________
Date: ____________