Experience

SGS proderm

• Germany
• Research Services
• 1 - 100 Employee

• Business Development Manager

  • Jul 2022 - Present



Eurofins bioskin

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Projektmanager

  • Mar 2020 - Jul 2022

   Project management of clinical trials: planning, execution and evaluation of clinical studies with investigational medicinal products (IMP) and medical devices, including budget control and timeline management in adherence to the applicable directives, guidelines, laws and SOPs; Close communication with internal and external stakeholders; including interface management of project teams; Status reporting; Writing of study specific manuals and plans; Vendor management (including but not limited to: IMP, Laboratories, Pharmacovigilance, Dermatological Photographies, ECG etc.); (e)TMF maintenance and quality control; Development and update of SOP related templates.

• Clinical Trial Manager

  • May 2019 - Mar 2020

   Project management of clinical trials: planning, execution and evaluation of clinical studies with investigational medicinal products and medical devices, including budget control and timeline management in adherence to the applicable directives, guidelines, laws and SOPs; Close communication with internal and external stakeholders; including interface management of project teams; Preparation and execution of submission packages (IEC/IRBs/ Local Authorities) (initial submission, amendments and notifications);  Support organizing investigator meetings; Vendor Management; TMF maintenance.

• Clinical Trial Management Assistant

  • Aug 2018 - May 2019

   Overall support of Clinical Trial Manager; Support in preparation and execution of regulatory process (IEC/IRBs/Local Authorities) including preparation and collection of project-specific documentation, initial submission/ amendments and notifications;  Support in organization of Investigator Meeting, Site Initiation/Close out Visit and other project-related activities; Preparation and maintenance of TMF and IF; Support in preparation and maintenance of timelines and status reports;



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• In-house CRA III

  • Nov 2008 - Sep 2017

   Preparation and submission of clinical trial applications, amendments and notifications to RA/(L)ECs; Review and adaptation of core trial documents to local regulations (ICF, IMP labels, patient cards/diaries, investigator contracts etc.); Communication with internal and external stakeholders; Import/export of IMP/CSM: preparation of documents required for customs clearance; Submission of Safety Information (CIOMS SAE reports) to RA and ECs; Assist project team in preparation of investigator meetings, site initiation and other project-related activities; eTMF/CTMS maintenance; Oversight of assistants; Development and update of SOP related templates.



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Clinical Operation Specialist II

  • Apr 2007 - Apr 2008

  Same responsibilities as for In-House CRA III Same responsibilities as for In-House CRA III



Worldwide Clinical Trials

• United States
• Research Services
• 700 & Above Employee

• Drug and Clinical Supply Depot Manager, Pharmacist

  • Apr 2006 - Apr 2007

  Drug and Clinical Supply Depot Manager, Pharmacist  Generation of accompanying documents for outgoing IMP/Clinical Study Material (CSM) shipments; Tracking of incoming/distributed Investigational Medicinal Product and other CSM in Database; Perform IMP re-labelling, including expiry date extensions and study-specific labels; Organization of IMP destruction at licensed disposal companies; Regular control of temperature and humidity mapping for storage of investigational medicinal products; Perform quality control of outgoing IMP/CSM shipments; Support for the Clinical Department and Study Sites/Investigators.

• Office Manager

  • Apr 2006 - Dec 2006