Clinical Research Manager

• Extensive experience in clinical research management across Phase II–IV, non-interventional and medical device studies with strong end-to-end project oversight

• Proven expertise in site management, clinical monitoring, study start-up activities, CTIS submissions and regulatory compliance in Germany, Austria, and Switzerland

• Strong background in stakeholder management, including collaboration with Key Opinion Leaders, Ethics Committees, investigators, and cross-functional study teams

• Was placed as a Senior Clinical Trial Associate with best references via K-Recruiting

Summary of Responsibilities within the projects as comprehensive clinical resarch manager for Phase II-IV trails and non-interventional trials in Germany, Austria and Switzerland:

• Site identification and feasibility

• PM contacts with Key Opinion Leaders

• Review of inclusion exclusion criteria and the proper consenting of all subjects

• Site selection and qualification visits

• Writing of Informed Consent Form

• Writing of Monitoring Plan

• Assist with obtaining approval from local Ethics Committees and Institutional Review Boards via EU Portal CTIS

• Contract negotiations and Budget calculations

• Managing subject recruitment

• Review of quality systems at the site and ensuring all sites are audit ready

• Initiation, interim monitoring, and study closure visits

• Essential document collection, review and processing

• Good Clinical Practice monitoring, including motivational and training visits

• Co-Monitoring of QA-Action

• CAPA plan development and implementation

• Source documentation review, CRF review and query resolution

• Accountability for all study documents and materials

• Communication with sites

• Study specific training to site personnel and CRAs

• Review of Investigational Product accountability and storage

• Review of safety information of all subjects

• Logging and correcting protocol deviations

• Risked-based Monitoring study progress

• Database lock and study close out

• Organizing Investigator Meetings

• Organise, maintain and complete the paper and electronic trial master files

• Identify, request and ensure delivery of outstanding and outdated documents

• Periodically, and at the end of the study, review study files / folders for organization and completeness

• Assist in setting up clinical study files / folders at study sites and assist in quality review of the study site files / folders throughout the study

• Assist the clinical operations project managers, by offering support for day-to-day study management activities

• Perform various study related functions as required and assigned

• To perform any other activity as may reasonably be required from time to time

• All aspects of financial coordination and personnel planning

• Organization of International Stem Cell Meetings for the research projects

• Presentation at different meetings e.g. Kick-off Meeting and Internal Progress Meetings

• Central point of communication for all groups, regulatory affairs and ethics committee related issues

• Close and direct contact to each group (weekly telephone conferences with the Steering Committee)

Therapeutic Experience:

• Cardiovascular studies (Pulmonary Hypertension, Portal Hypertension, Primary Biliary Cirrhosis, Diabetes mellitus, Hepatitis C and HIV)

• Eye care (Diabetics Macular Edema, Open Angle Glaucoma and Gene therapy with neovascular age related Macular degeneration)

• Neurosurgery (Aneurysmal Subarachnoid Hemorrhage (aSAH))

• Cancer studies (pre-treated advanced Melanoma, Bladder Cancer and gastrointestinal Cancer)

• Migraine studies

• Peanut Allergy

• Vaccine studies

• Pre-clinic studies

• Medical Device studies

• Non-interventional studies