Clinical Research

• Lead and manage international clinical studies from study start-up through close-out, ensuring delivery on time, within budget, and in compliance with applicable regulations.
• Coordinate investigator sites across Europe and internationally, providing operational support throughout the study lifecycle.
• Manage study timelines, budgets, documentation, clinical systems, and trial dashboards.
• Oversee external vendors, Investigator Meetings, and collaborations with Principal Investigators (PIs) and Key Opinion Leaders (KOLs).
• Monitor study progress, identify risks, and drive timely issue resolution to ensure successful study execution.
• Support clinical data review, regulatory submissions, and study reporting.
• Partner with cross-functional teams including Regulatory Affairs, R&D, Medical Affairs, Quality, Marketing, and Commercial.
• Drive compliance with ICH-GCP, QMS, and applicable regulatory requirements while contributing to continuous process improvements.

Clinical Study Manager, Neurovascular

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Verifies issues or risks associated with blinded or randomized information related to IP
• Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
• Reconciles contents of the ISF with the Trial Master File (TMF)
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• Supports subject/patient recruitment, retention and awareness strategies
• Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
• Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets
• May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA)
• Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
• Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions

Clinical Trial Manager

• Travelling to study sites (Germany-wide) to conduct qualification, initiation, monitoring, and closeout visits in compliance with the approved protocol
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
• Verification that the investigator is enrolling only eligible subjects
• Regulatory document review
• Medical device and/or investigational product/drug accountability and inventory
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Clinical Research jobs in Germany

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Clinical Study Manager, Neurovascular

Clinical Trial Manager

Clinical Research Associate, Virtual Event