Central Monitor

2 days ago

Ahmedabad, India Cliantha Research Full time

Central Monitor

PRINCIPAL DUTIES AND RESPONSIBILITES:
A. Manage assigned studies with mínimal supervision.
B. Contribute to the development and use of Central Monitoring Plans and/or RBM specific tools and
templates and/or other study specific plans.
C. Support project management team to develop monitoring strategy including monitoring
triggers/thresholds.
D. With guidance, provide Inputs to clinical study teams, key decision makers, and internal team
members to manage continuous process improvements, issue escalation, workload projections.
E. 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.
F. Preparation of Site Performance Matrix (SPM) Tool for respective sites for assigned study (ies).
G. 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.
team.
I. 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.)
J. Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project
team
K. Conduct periodic review of KRls, Trend Analysis points and share the output with Project Team.
L. Monitor site performance and make recommendations for timely corrective actions (e.g. Site
Telephone Contact or Triggered Onsite Monitoring Visit)
M. Work in accordance of the Study Specific Central Monitoring Plan.
N. Establish and maintain effective project/ site level communications with relevant stakeholders.
O. Perform Source Data Verification (SDV) as per defined scope for the study.
P. To liaise with other departments within the organization for timely achievement of the project
milestones.

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