Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Summarized Purpose:

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required
documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial
is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops
team-oriented relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix

Essential Functions
- Monitors investigator sites using a risk-based monitoring approach.
- Applies root cause analysis (RCA), critical thinking, and problem-solving skills to:
- Identify site process failures.




- Determine corrective and preventive actions.
- Bring sites into compliance.
- Reduce study and site-level risks.
- Ensures data accuracy through:
- Source Data Review (SDR).
- Source Data Verification (SDV).
- Case Report Form (CRF) review, as applicable.
- On-site and remote monitoring activities.
- Assesses investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management promptly and follows issues through to resolution.
- Maintains regular contact between monitoring visits with investigative sites, as needed, to confirm:
- Protocol compliance.
- Resolution of previously identified issues.
- Timely recording of study data.
- Conducts monitoring activities in accordance with the approved monitoring plan.
- Participates in the investigator payme

📌 Cra I (Mumbai)
🏢 Thermo Fisher Scientific
📍 Mumbai