Central Monitor

2 weeks ago

Ahmedabad, India Cliantha Research Full time

**Position: Central Monitor**

**Department **Central Contracts & Proposal
**Basic qualification required **B.Pharm / M. Pharm, M.Sc

**Brief JDs Job Description:
- Manage assigned studies with mínimal supervision.
- Contribute to the development and use of Central Monitoring Plans

and/or RBM specific tools and templates and/or other study specific
plans.
- Support project management team to develop monitoring strategy

including monitoring triggers/thresholds.
- With guidance, provide Inputs to clinical study teams, key decision

makers, and internal team members to manage continuous process
improvements, issue escalation, workload projections.
- Perform centralized monitoring activities on assigned projects and

evaluate the quality and integrity of the study as per the protocol,
Sops respective regulation and guidelines.
- Preparation of Site Performance Matrix (SPM) Tool for respective

sites for assigned study (ies).
- Participate in (study) team meetings/Project kick off meetings, client

meetings and interaction with cross functional staff to verify
information and/or triage new data issues.

stakeholder within the project team.
- Perform Subject Level Data Review that require further investigation

with the clinical site to determine overall accuracy (inclusion &
exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.)
- Perform the activities delegated and/or act as back up for/to relevant

stakeholders within the project team
- Conduct periodic review of KRls, Trend Analysis points and share the

output with Project Team.
- Monitor site performance and make recommendations for timely

corrective actions (e.g. Site Telephone Contact or Triggered Onsite
Monitoring Visit)
- Work in accordance of the Study Specific Central Monitoring Plan.
- Establish and maintain effective project/ site level communications
- with relevant stakeholders.- Perform Source Data Verification (SDV) as per defined scope for the
- study.- To liaise with other departments within the organization for timely

achievement of the project milestones.

USA | CANADA | EUROPE | INDIA

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