Bergisch Gladbach, North Rhine-Westphalia, Germany
Clinical research professional with over 7 years of experience in the operational oversight and execution of global clinical trials within biotech and CRO settings. Skilled in clinical monitoring, site feasibility and startup activities, vendor and budget management, inspection readiness, regulatory oversight, and TMF management. Brings strong communication skills in both English and German and thrives in multicultural, cross-functional teams across early- and late-phase trials.
Project: pivotal Phase III Oncology study, 200+ sites, 400+ patients Cross-functional Clinical Trial Team (CTT) Management Activities • Responsible for oversight of the study conduct within the applicable timelines, budget, and quality standards in collaboration with the project manager • Management and coordination of the study Risk Assessment Management Log and Issue Log • Coordinating inspection readiness activities and collaborating with CTT to ensure all aspects of the trial are inspection ready • Preparing and reviewing clinical trial documentation, including protocols, informed consent forms, study reports, and regulatory submissions • Maintaining a comprehensive vendor invoicing and study budget tracking system, enhancing transparency and efficiency in clinical trial cost management • Managing the following study aspects: study insurance, vendors systems access, internal/external SOPs review process, and CSR appendices preparation • Developing and monitoring internal processes as patient ICFs tracking and patient withdrawal • Leading CTT meetings, organizing CTT trainings, and onboarding of the new CTT members eTMF Activities • Responsible for TMF maintenance including collection and filing of study documents • Leading TMF QC activities ensuring TMF submission/inspection readiness Internal and external follow-ups on quality issues and tracking the progress • Overseeing documentation flow within projected timelines and determine course of action needed to prevent and remediate delays/errors Regulatory Activities • Management and oversight of CRO regulatory teams’ activities, ensuring compliance with applicable regulatory standards. Monitoring and assessing their performance against predefined benchmarks • Ensuring timely submission of application/documents to EC/IRB at start up and for the duration of the study. Prepared responses to regulatory agencies' questions/requests
Therapeutic areas of specialty: ophthalmology, dermatology, immunology (Phase II/III trials) • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits • Ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. • Assess factors that might affect the subject/patient's safety and clinical data integrity at an investigator/physician site • Provide guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
Therapeutic areas of specialty: oncology, hematology, ophthalmology, dermatology, immunology, renal diseases (Phase I/II/III trials) • Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, Medpace/Sponsor SOPs, and applicable regulatory requirements • Responsible for overall site management for assigned sites, including written and verbal communication and scheduling of monitoring visits • Responsible for completion of visit reports, follow-up letters, and maintenance of study-related databases
Working on a clinical trial investigating the usage of a probiotic formulation for patients with Schizophrenia/Bipolar Disorder who have screened positive for increased intestinal permeability. • Preparing and submitting Ethical Committee applications and maintaining Trial Master File • Development of clinical protocols, amendments, and patient Informed Consent Forms