Job Description

Job Description: Medical Monitors

Qualification: MBBS with any PG or DNB or Diploma.

Experience: 2 - 4 Years’ Experience in Clinical Research Filed.

- Provide protocol and therapeutic area training to study teams (both internal and external).

- Provide response to PI/site/EC queries.

- Prepare medical monitoring plan

- Review of PDs

- CSR/SMP/SAP review

- Review study subject reports (like lab reports, ECG report, cytology, 2D- ECHO, CT, Bone Scan reports, , any assessments etc, as applicable) for eligibility in coordination with Project Manager/Designee.

- SAE management if any, follow up with sites/ investigator for SAE updates and updating sponsor accordingly.

- Review and develop amendments (if required) to Protocol and other study documents such as Safety Monitoring Plan, expedited reporting plans, eligibility review plan.

- Liaison with investigators and sponsor medical monitor for any medical queries.

- Responsible for review of AE and SAE data in the clinical trial for its completeness and accuracy

- Responsible for review of SAE forms received from Sites.





- To communicate various safety related aspects with the stake holders i.e., Study team to site, and various regulatory agencies and Sponsor’s team.

- Responsible for preparation of SAE reporting “Data Elements for Reporting Reliable Adverse Events Occurring in A Clinical Trial or Bioavailability or Bioequivalence Study”.

- Responsible for coordination with internal Regulatory and operation team for completion of SAE forms, reconciliation and tracker compilation.

- Responsible for ensuring electronic reporting of SAEs to DCGI, Chairman of Ethics Committees and Head of Institutions within stipulated timelines.

- Responsible for Preparation of individual case narratives.

- Responsible for preparation of the CSR.

- AE, Concomitant Medication, Medical History, Vital signs, Physical examination, I/E listing review.

- Review the blinded study data on regular periodic basis

Job Snapshot

Updated Date

06-11-2021

Department

Clinical Research

Location

Miyapur, Hyderabad, Telangana, India

Employee Type

Full Time - 30

📌 Medical Monitor (Miyapur)
🏢 AXIS Clinicals
📍 Miyapur