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  • Associate-Clinical Research Management (Pharma, Biologics and Medical devices) Electives: 1. Site management, 2. Study Monitoring, 3. Data management, 4. Biostatistics

Associate-Clinical Research Management (Pharma, Biologics and Medical devices) Electives: 1. Site management, 2. Study Monitoring, 3. Data management, 4. Biostatistics

NQR Code:QG-5.5-LS-00251-2025-V2-LSSSDC

  • Old Code: QG-5.5-LS-00251-2025-V2-LSSSDC

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About this Qualification

Job Description

Associate-Clinical Research Management (Pharma, Biologics and Medical devices Facility) supports clinical trial activities, carries out reporting and documentation for monitoring of research activities to ensure regulatory compliance and current Good Clinical Practices (GLP) as per ICH and coordinates with site staff members, investigators, Site Management Organization and Sponsor. The role holder is expected to assist in the Biostatistics analysis of clinical trial data with the help of artificial intelligence.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
Completed 3rd year of 3-year/ 4-years UG Completed No Experience None
Completed 3rd year of 3-year/ 4-years UG Completed No Experience None
Completed 3rd year of 3-year/ 4-years UG Completed No Experience None
UG Completed No Experience None

Progression Pathway

  • Not applicable

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Introduction to life sciences industry and basic of Clinical trial occupation LFS/N3507, v1 Mandatory 30 1.00 5.5
Ensure environment sustainability and sensitivity towards all genders and people with disability LFS/N0119, v3.0 Mandatory 30 1.00 5.5
Carry out management activities related for clinical trial LFS/N3506, v1 Mandatory 30 1.00 5.5
Employability Skills (90 Hours) DGT/VSQ/N0103, v1 Mandatory 90 3.00 5
1: Site Management: Perform site management activities at clinical research site LFS/N3503, v3 Elective 210 7.00 5.5
1: Site Management : Carry out reporting and documentation for site coordination activities as per regulatory standards LFS/N3504, v3 Elective 180 6.00 5.5
2: Study Monitoring : Monitor the clinical trial site to ensure that ICH GCP guidelines, study protocol and applicable regulations are followed LFS/N3501, v3 Elective 210 7.00 5.5
2: Study Monitoring: Carry out reporting and documentation for site monitoring activities as per regulatory standards LFS/N3502, v3 Elective 180 6.00 5.5
3: Data management : Provide support for clinical data management activities LFS/N3505, v3 Elective 390 13.0 5.5
4: Biostatistics: Provide support through Biostatical analysis LFS/N3508, v1 Elective 120 4.00 5.5
4: Biostatistics: Provide support in PK & PD through Biostatistics analysis LFS/N3509, v1 Elective 120 4.00 5.5
4: Biostatistics: Provide algorithm support for Biostatistics activities LFS/N3510, v1 Elective 120 4.00 5.5
4: Biostatistics: Apply AI/ML Models in biostatistical analysis LFS/N3511, v1 Elective 30 1.00 5.5