Clinical Project Manager

10/2018 – 4/2019

Study phase: NIS
Fully sponsor dedicated to Hexal AG/Sandoz International GmbH
Site Location: Poland

Preparation and conduct of site initiation visits (together with a interpreter)
Proactive site maintenance and provision of oversight through risk- based monitoring approaches (e.g. remote visits)
Effective communication with Covance Project Team members (i.e. Project Managers, Safety and Data Management) as well as the Sponsor Project Team to ensure study completion per company and client requirements and timelines
Proactive communication with CRAs and study sites to follow-up on all open issues, drive patient recruitment and retention, in order to meet project timelines
Development of a thorough understanding of the contract and scope of work to support financial progress

Good clinical practice (GCP), Klinische Monitor (CRA), Klinische Studie, Medizinforschung, Pharmaforschung, Projektleitung / Teamleitung

4/2018 – 10/2018

Study phase: NIS
Fully sponsor dedicated to Hexal AG/Sandoz International GmbH
Site Location: Germany, Austria, Switzerland (DACH)

Preparation and conduct of site visits: qualification, initiation, monitoring and audit support visits according to relevant SOPs, local requirements, the protocol and project plans as well as providing timely and comprehensive visit and status reports
Effective communication with Chiltern Project Team members (i.e. Clinical Team Leader, Project Manager, Safety and Data Management) to ensure study completion per company and client requirements and timelines
Support in the creation of CRA working tools
Central point of communication with study sites and issue follow-up
Investigator site files management, reconciliation and QC against the TMF files
Mentoring less experienced CRAs on project tasks
Additional responsibility for TMF oversight and CRA training requirements for the study
Audit experience

Good clinical practice (GCP), Klinische Monitor (CRA), Klinische Studie, Medizinforschung, Pharmaforschung

10/2015 – 11/2017

Study phase: III

CRA team management and organization (work allocation and performance appraisal during interim analyses, organization and realization of telephone conferences, vacation replacement for the clinical study manager, assistance with inspection preparations)
Liaising with local finance and contract functions as well as the global clinical team
Vendor management
Organization of local study team meetings including development of presentations and workshops for continuous training of CRAs
Quality management (review of monitoring reports, execution of CRA assessment visits to ensure CRA compliance to corporate policies, procedures, and quality standards)

Good clinical practice (GCP), Klinische Monitor (CRA), Klinische Studie, Medizinforschung, Pharmaforschung

3/2014 – 11/2017

Study phases: II, III, IV as well as NIS
Site Location: Germany, Switzerland (since 09/2014)

Site Selection Visits (determining the suitability of sites, preparing documents for submission to the Ethics Committee)
Site Qualification Visits
Site Initiation Visits
Monitoring Visits (supporting sites in their process optimization, performing on-site training, source data review and source data verification, monitoring of essential ICH/GCP documents and investigator folder, writing monitoring reports, remote monitoring and remote review, risk-based monitoring and site management)
Close-Out Visits
Issue management (resolving site operational issues, escalating site performance issues to clinical study manager if necessary)
Health authority inspection experience

Good clinical practice (GCP), Klinische Monitor (CRA), Klinische Studie, Medizinforschung, Pharmaforschung