Mangi L.

Engaged in clinical trials focused on various indications, assuming the role of CRC in studies involving Pneumococcal vaccine, Respiratory syncytial Virus, Sickle Cell Disease, and others, adhering to protocol guidelines and facilitating regulatory compliance.

Involved in clinical trials for Ulcerative colitis and Crohn’s Disease, managing medication accountability and ensuring adherence to unblinding protocols.

Participated in studies related to Acute coronary syndrome and type 2 Diabetes, carrying out responsibilities in compliance with clinical trial protocols and contributing to data integrity and regulatory documentation.

Supported study start-up activities, which included site feasibility assessments, site qualifications, and the preparation of ethics committee submissions. Coordinated with Principal Investigators and site personnel for subject screening, enrollment, and adherence to protocol-defined study visits. Served as the main point of contact for CROs and Sponsors, addressing operational queries related to ongoing clinical trials. Maintained all essential documentation, such as source documentation and study logs, ensuring compliance with ICH-GCP and NDCT 2019 standards. Conducted eCRF data entry and managed query resolution to guarantee data integrity and timely updates. Assisted with adverse events, serious adverse events, and protocol deviations, ensuring accurate documentation per regulatory timelines. Provided monitoring support during site initiation, interim monitoring, and close-out visits, both on-site and remotely. Ensured audit and inspection readiness by maintaining complete and compliant documentation. Oversaw IMP/IP receipt, storage, and accountability while coordinating with vendors and suppliers for logistical support related to study materials. Addressed site-level issues to facilitate seamless and compliant study execution.