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Associate Clinical Manager

0-4 years
Not Disclosed
10 June 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: Associate Clinical Manager

Experience Required: 0 – 4 years
Job Type: Full Time
Location: Shivalik
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 for preparation of Protocol.

  • Assist with the development of the Informed Consent Form (ICF) and Case Report Form (CRF).

2. Ethics Submission

  • Work with the investigator to submit study-related documents and updates to the Independent Ethics Committee.

3. Study Management

  • Assist investigator in study schedule planning.

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

  • Ensure volunteers are eligible and fit for participation per study protocol.

  • Conduct ICF presentations for potential study participants.

  • Perform clinical examinations and monitor vitals throughout the study duration.

  • Safeguard subject safety and handle/report adverse events, reactions, and clinical emergencies.

  • Make clinical decisions in the absence of the investigator and seek their input as necessary.

  • Supervise nursing staff in maintaining emergency medicine and Special Care Room preparedness.

  • Offer medical assistance to both study subjects and employees.

  • Oversee and ensure that clinical studies are compliant with the approved protocol, ICH-GCP guidelines, and internal SOPs.

  • Coordinate subject admission, discharge, meal distribution, dosing activities, and monitoring for compliance.

  • Generate and maintain all essential documents for each study.

4. Report Preparation

  • Document protocol and SOP deviations during clinical assessments and vital checks.

  • Collaborate with the investigator to include these in the final study report.

5. Feasibility Assessment

  • Support feasibility analysis of new molecules by working with clinical research teams.

6. Other Duties

  • Perform any additional tasks as directed 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: ____________