Monica Vogel Email & Phone Number

Arizona, United States

• Allakos Inc. San Carlos, CA – Contractor October 2023 to Present
• Collaborates with the Clinical Trial Manager (CTM) on trial management, logistics, and administrative tasks, including study start up (CDA, CTA, feasibility), and study close out activities (Document review, data sign.
• Ensure accurate data entry in trackers and managing clinical and non-clinical supplies.
• Track and monitor study progress, including enrollment, regulatory documentation, and site start-up, alongside maintaining, reconciling, and archiving Trial Master Files (TMF) for 2 clinical trials, ensuring 100%.
• Maintain oversight of CROs, vendors, investigators, and monitor. Providing support for external access to study information, and coordinating Confidential Disclosure Agreements (CDAs) and contracts with internal.
• Assists in organizing clinical sub-team meetings, investigator and vendor meetings, manages meeting minutes.

Munich, Bavaria, Germany

• Monitored study compliance and progression, including document preparation, feasibility, site qualification, site startup, interim monitoring visits, and site closeout in accordance with GCP and sponsor SOPs..
• Conducted monitoring visits, source data verification, and monitored investigational product accountability to ensure trial sites met protocol and regulatory requirements. Provided thorough training to study personnel.
• Proactively identified risks, and developed mitigation plans for sites with help of CTM.
• Maintained accurate documentation of all monitoring activities. Filed all documentation in the Trial Master File, and maintain the eTMF according to the sponsors eTMF plan.

Munich, Germany

Master Of Science - Ms, International Public Health/International Health

Bachelor Of Science - Bs, Physiology, General