Michael Hagan Email & Phone Number

San Francisco, Ca, Us

Flemington, Nj, Us

Flemington, Nj, Us

Cincinnati, Oh, Us

Leverkusen, North Rhine-Westphalia, De

• Manage US study operations for internal and CRO run Phase II, III, and EAP clinical trials in Oncology, Metabolics, Cardiology, and Imaging• Conduct feasibility assessments for the US on global studies providing US timelines, planned enrollment rates, potential obstacles, and study budget• Perform the Site Selection Process by working with the Medical Affairs Team and expert coordinating Investigators to select the most appropriate US sites• Create and review all essential documents for US sites including but not limited to ICF, Pregnancy ICF, Study Withdrawal ICF, Assent Form, and Pediatric Consent Form• Manage the CRA team assigned to these trials in day-to-day activities assuring that all trial conduct is performed correctly in accordance to ICH/GCP and Bayer SOPs• Develop and present training material with the study medical expert for investigator meetings, monitor training and materials used for site selection and site initiation visits.• Work closely with the monitoring team to ensure study timelines are met.• Create and manage US trial budget and contracts and account for site payments, vendor payments, steering committee member payments, DSMB payments, and coordinating Investigator payments according to achieved study milestones and data entry. • Perform CRA oversight visits• Work with auditing and study medical experts to overcome unanticipated obstacles throughout the course of the trial. • Trained and mentored new CLMs in accordance with the Peer Resource Program• Liaise/collaborate with Medical Affairs personnel as required prior to investigative product launch

Leverkusen, North Rhine-Westphalia, De

• Monitoring experience in phase II and III clinical trials in hematology, metabolics, cardiovascular disease, oncology and imaging• Perform site selection visits, site initiation visits, periodic monitoring visits and close out visits according to Bayer HealthCare SOPs, ICH/GCP guidelines and FDA regulations• Conduct by-patient review/data cleaning ensuring adherence to study timelines on an ongoing basis• Work independently to define regional territory by identifying new Investigators• Assist Study Management Team during Study feasibility process• Conduct Rave/eCRF User Acceptance Testing• Responsible for managing and updating the CRA Manual for the Department of Monitoring• Present training for several new or changed SOPs to the Department of Monitoring• Conduct co-monitoring visits with new hires to assist with their acclimation to the Bayer environment• Mentor for several new CRAs in accordance with the Peer Resource Program

Basel, Baselstadt, Ch

• Part of a Flex Team for the company that monitors various Therapeutic Areas from Phase II-IV• Carry out Site Selection, Site Initiation, Periodic Monitoring and Study Close Out Visits• Work independently to define regional territory by identifying new Investigators• Review daily with the Project Manager to make sure that study timelines are maintained• Assist in the review of the new Investigators in the Michigan area for possible Clinical Trial participation• Train new hires to the company within the given Midwest region• Very knowledgeable in ICH/GCP Guidelines and FDA Regulations

Bachelor Of Science (Bs), Sociology

Pre-Medicine/Pre-Medical Studies