- Conduct on-site and remote monitoring visits, including Source Data Verification (SDV) and Source Data Review (SDR), across global Oncology clinical trials.

- Work across Phase 0 and Phase III interventional and non-interventional studies, including randomized trials.

- Coordinate issue resolution between site staff, Data Management, vendors, and other functions; escalate issues when required.

- Track outstanding actions and follow up through closure.

- Communicate directly with Sponsor/Study Team regarding study-related operational matters and site issues.

- Support implementation of new processes and systems and coordinate related site retraining.

- Coordinate with vendors on study-related operational matters and follow-up activities.

- Identify, document, report, and follow up on protocol deviations and other site issues.

- Review informed consent forms and source documentation for compliance with protocol requirements, ICH-GCP, ALCOA principles, and applicable regulations.

- Track and follow up Serious Adverse Event (SAE) reporting, including reports, narratives, and required follow-up.

- Compile, review, and maintain regulatory documentation and support Regulatory Submissions.

- Collaborate with site staff and Data Management to resolve data queries and support data integrity in eCRF and other data collection tools.

- Review site-specific logs, delegation records, screening and enrollment documentation, and Investigational Product (IP) accountability records.

- Support audit readiness and perform site close-out activities.

- Maintained clinical trial trackers and study documentation and followed up on missing, expiring, or inconsistent documents with CRAs.

- Supported IRB/IEC submissions and contract preparation activities.

- Customized and distributed essential documents, trial materials, and study communications to investigational sites.

- Maintained Trial Master File (TMF) essential documents at country and site levels.

- Performed periodic country-level TMF Quality Control (TMF QC) reviews and followed up on findings through resolution.

- Participated in preparation of regular study activity reports.

- Prepared researcher payments, non-IP product payments, and related study documentation.

- Reviewed vendor invoices and supported document archiving.

- Coordinated distribution of study supplies, including laboratory kits and questionnaires, to investigational sites.

- Organized and coordinated study-related operational activities.

- Consulted patients and performed specialized diagnostic evaluations.

- Analyzed medical histories and diagnostic data to support clinical decision-making.

- Collaborated with other medical specialists, including oncologists.

- Maintained accurate medical documentation.