Projektmanagement, Monitoring

1/2016 – 12/2017

Identifikation, Training, Entwicklung und Resourcenplanung von 15 CRAs und 7 CTAs. Durchführung von Begleitbesuchen zur Sivcherstellung, dass die Studien gemäß ICH-GCP durchgeführt werden.

Personalführung, Personalplanung, Recruiting, Talentmanagement, Projektmanagement - Personalmanagement, Konfliktmanagement, Team Building

5/2008 – 12/2015

Identifikation, Training, Entwicklung und Resourcenplanung von 12 CRAs und 1 jr. Linemanager. Durchführung von Begleitbesuchen zur Sicherstellung, dass die Studien gemäß ICH-GCP durchgeführt werden.

Klinische Arbeiten, Klinische Forschung, People Soft, Personalführung, Personalplanung, Recruiting, Talentmanagement, Konfliktmanagement, Team Building

2/2005 – 4/2008

Responsible for global protocol and site feasibility assessments and adequate site selection. Ensured
the timelines and quality of study deliverables in accordance with SOPs, ICH/GCP guidelines and local
regulations.
Strategically planned and coordinated trials (forecasting, resourcing, timelines). Tracked local trial
implementation, data collection and study reporting. Reviewed and approved of monitoring visit reports
and site initiation process in risk based monitoring model. Prepared and participated in 3 coordinated
GCP site inspections from local supervising authorities. Prepared of coordinated GCP Sponsor
inspection from local supervising authority. Prepared of and participation in one internal audit. Supervised
actions for preparations of site audit. Provided regular updates on study progress to line manager and
therapeutic area (included identifying barriers to site activation/patient enrolment and identifying potential
solutions). Ensured quality of study execution and escalated study-related issues. Participated and
presented at investigator meetings. Coordinated local study team tasks (up to 12 local study managers).
Ensured CRA received necessary TA-related and study-related trainings. First point of contact for
several Sponsors

Projektfinanzierung, Projektleitung / Teamleitung, Projektmanagement, Konfliktlösung, Projektmanagement - Risikomanagement, Projektplanung / -vorbereitung

2/2003 – 2/2005

Responsible for trial conduction in the EU (up to 6 countries). Categorized protocol deviations for
evaluation of data for database lock and participation in data review meeting for final data evaluation
of study results. Served as main sponsor contact for CRO field monitors. Ensured that all trial close–
out activities are performed in close cooperation with CRO field monitors and ensure monitoring visits
are performed according to monitoring plan. Reviewed monitoring visit reports to identify
quality/compliance issues that required escalation and/or require follow up with the CRO field monitors
for resolution with the sites. Provided governance on TMFs maintained by the CRO. Reviewed TMF
binders for completeness, and to identify quality/compliance issues. Administrative completion of
documents for FDA-submission. Reviewed of clinical study report/input in clinical study report. Coordinated
of compilation of CSR appendices for the submission to regulatory authorities.
As a Clinical Team leader, participated in numerous clinical trials, phases II-IV in different therapeutic
areas. Performed all tasks required for the Clinical Team lead position.

Klinische Arbeiten, Klinische Forschung, Projektmanagement - Kommunikation, Projektmanagement - Personalmanagement, Projektteambildung / -entwicklung

12/1998 – 1/2003

Clinical Research Associate: Performed management of clinical trial management system, and writing of
monitoring visit reports. Performed co-monitoring visits for pre-study, initiation, interim monitoring visits.
Conducted of site selection, initiation, and interim monitoring visits, and training of site personnel.
Collected site documents for Ethic submissions, re-label of study drug (extension of expiry-date) and
performed trainings with regards to ICH-GCP/AMG, SOPs and on clinical indications.
As a Clinical Research Associate, participated in numerous clinical trials, phases II-IV in different
therapeutic areas and indications. Performed all aspects of clinical monitoring, performed all types of
visits, served as primary contact for sites.

Klinische Arbeiten, Klinische Forschung