Heike Grüske

Clinical Trial Management of an international phase 3 study; COVID-19 vaccine

Project management of two pharmacokinetik studies at a phase I unit located in China.

International phase III study. Indication: acure myleloid leukemia. Monitoring of all sites located in Germany.

Actinic keratosis Phase IV study: monitor of 4 up to 17 sites in Germany and Austria - Monitoring of 8 sites until September 2014 - Monitoring of 17 sites since October 2014 including data cleaning and close out visits of all sites - TMF completion

Medical device Phase IV study, Sweden • Coordination of study start up activities with CRO including: o Review of clinical trial protocol, coordination of review of all involved departments o Site selection including site selection visits o eCRF creation o Creation of worksheets o Medical device availability o Review of EC submission documents o Site initiation visit co-monitorin

Actinic keratosis Phase IV study: crosscheck open query listings versus answer listing Clinical trial to assess the efficacy of a fixed combination therapy in treatment of radiation-induced oesophagitis: crosscheck monitoring plan after CRO change and review of monitoring reports Actinic keratosis Phase IV study: monitor and study manager

Actinic keratosis Phase IV, International, Multicentre Study: • Monitoring of 4 up to 12 sites in Germany and Austria • Preparation of the submission documents for regional council of German sites NSCLC Study, Phase IIb, International, Multicentre Study: • Preparation of the submission documents for CA, ECs and regional council of German sites • eTMF • investigator contract management • Preparation of contact lists for IP shipment, central and local laboratories, eCRF contract partner

Actinic keratosis Phase IV, International, Multicentre Studies: • Review monitoring reports • Review SAE reporting • Review project management plan, monitoring plan, CRF manual • Investigator meeting: presentation of the CRF and GCP Quiz • Review study material like ISF TOC, working sheets, pocket card, etc

NHL 1, Investigator initiated Trial, National, Multicentre Study: • Source data verification (retrospectively, trial performed between 2003 and 2006) • Work on DCFs prepared by data management • Correction of findings detected during monitoring visit by manual DCF • Review of reported SAEs and verification whether additional SAEs occurred • Documentation of follow up information • Open/completion the investigator site file • Collection of essential documents

Multiple Sclerosis Phase III, International, Multicentre Study: • Support of monitors located in GB, NL, Poland, Chile, France, Canada • Study site activation • study management • Monitor training Support • monitoring plan update • Case narratives Diabetes Study, Phase IV, National, Multicenter Study: study management COPD Phase IIIb, International, Multicenter Study: study management

Studienkoordination, TMF, Gestaltung studienspezifischer CRF Seiten, Organisation Prüfermeeting, Kick-off meeting, Erstellung Monitoring Plan

Versand und Änderungsbearbeitung von Prüfarztverträgen, Vorbereitung und Versand der Unterlagen für die Ethikkommissionen, Studienkoordination, Durchführung Monitor Meeting

Coding CRFs, Plausibility Check, Datacleaning

Erstellen von CRFs, Codieren von CRFs, Plausibilitätskontrolle, Monitoring

Monitoring, Studienkoordination, Plausibilitätsprüfung der Daten

Monitoring, Studienkoordination, Datenbearbeitung