Manoj Kumar

• Lead global Phase II–III clinical programs across multiple therapeutic areas.

• Perform clinical and medical data review of AE/SAE narratives, listings, and outputs for accuracy, logic, and consistency with study protocols.

• Review and approve core clinical documents (Protocols, IBs, CRFs, ICFs, Clinical Study Reports).

• Collaborate with data management and safety teams on signal detection, reconciliation, and medical escalations.

• Conduct investigator meetings and protocol trainings to maintain quality and compliance.

• Ensure audit readiness, GCP adherence, and execution of studies within timelines and budgets.

• Support statistical review for outlier detection, data trends, and risk-based monitoring.

TECHNOLOGIES

Medidata Rave, Oracle Clinical, eTMF, CTMS, Argus Safety, MS Excel (data tracking), SAS Listings Viewer

• Oversaw global Phase II/III studies ensuring alignment between clinical, medical, and regulatory teams.

• Managed cross-functional project timelines, data integrity, and safety consistency across submissions.

• Provided medical review inputs to PV and QA teams to ensure regulatory compliance and readiness.

• Led risk management and data quality improvement initiatives within operational frameworks.

TECHNOLOGIES

Oracle Clinical, CTMS, eTMF, Medidata, Clinical Portal

• Conducted medical review and QC of clinical data for signal detection and reporting accuracy.

• Supported regulatory documentation preparation and submission compilation.

• Collaborated with investigators and data management to resolve data inconsistencies.

• Ensured data accuracy aligned with ICH-GCP and local regulatory standards.

TECHNOLOGIES

Medidata Rave, MS Access, Safety Database Systems, Excel Trackers

• Oversaw site-level data quality, SAE reconciliation, and ensured regulatory adherence.

• Reviewed clinical data for medical plausibility and protocol adherence.

• Acted as liaison between medical monitors, safety teams, and investigative sites.

• Supported audit preparation and data verification for inspection readiness.

TECHNOLOGIES

Oracle CTMS, eCRF, Medidata Rave, TrialMaster, Excel Audit Logs