Qc Manager Clinical Operations

Canvass Clinical Research Services; Nagpur District, Pune District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Canvass Clinical Research Services is seeking a Quality Control Manager to lead QC activities for clinical trial sites, including onsite and offsite visits to ensure adherence to SOPs, policies, GCP, and regulatory requirements.

You will review source documents, EDC, study logs, trackers and essential records for accuracy, completeness, timeliness and ALCOA compliance; and ensure site readiness for monitoring, audits and inspections through periodic QC visits, observation tracking, root-cause

Qualifications

Responsibilities

• Conduct Quality visits (onsite/offsite) across clinical trial sites to ensure compliance with SOP/policy.
• Review source documents, EDC, study logs, trackers, and essential records with compliance to the protocols, SOPs, GCP, Sponsor/CRO requirements, and applicable regulations for accuracy, completeness, timeliness, traceability, and ALCOA compliance.
• readiness of sites for monitoring, audit, and inspection through periodic QC visits, observation tracking, root-cause analysis, and CAPA closure.

Job description

Key Responsibilities Quality Control Manager

- Conduct Quality visits (onsite/offsite) across clinical trial sites to ensure compliance with orgnization SOP/policy

- Review source documents, EDC, study logs, trackers, and essential records with compliance to the protocols, SOPs, GCP, Sponsor/CRO requirements, and applicable regulations for accuracy, completeness, timeliness, traceability, and ALCOA compliance.

- readiness of sites for monitoring, audit, and inspection through periodic QC visits, observation tracking, root-cause analysis, and. CAPA closure.