Monitors the progress of the clinical activities in the assigned studies in accordance with Protocol, SOPs, applicable Regulatory & ICH/GCP guidelines and implements actions as necessary.
Plans and manages the project timelines and resources.
Participates in project meetings, provides regular updates to sponsors, and ensures maintenance of communication between team members and sponsors.
Contributes to the development of study-specific documentation, Project management plan and maintenance of Project Master File.
Review Monitoring visit reports relating to the clinical reports.
Ensures adherence of the local team to study timelines.
Trains CRA's & other local staff with regard to protocol, Case Report form (CRFs) & Study specific procedures.
Participates in, and jointly organizes meetings for investigators & CRA's.
Ensures the correct query process is followed in collaboration with data management.
Ensures correct reporting & follow-up of adverse events, serious adverse events & suspected unexpected serious adverse reporting.
Supports the study team during inspections by regulatory authorities or audits.
Ensures that information is conveyed effectively between the sponsor and the study team.
Assist in the development of in-house clinical operations SOPs.
Job Type: Full-time
Pay: ?15,864.19 - ?120,413.43 per month
Work Location: In person
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