Project Manager II/ Regional Team Leader DE, NL, AT and GR

• Sep 2023 - Present

Project Manager II/ Regional Team Leader DE, NL and AT

• Jul 2023 - Sep 2023

Project Manager II / Regional Team Leader DE and NL

• Oct 2022 - Jul 2023

Manages and coordinates the assigned clinical projects Manages all project specific services required by the Sponsor (centralized lab exams, drug shipments, documents shipment, etc.) Manages the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members Assures the proper timelines of the assigned projects Manages the budget of the project Plans and monitors the tasks of the team in… Show more Manages and coordinates the assigned clinical projects Manages all project specific services required by the Sponsor (centralized lab exams, drug shipments, documents shipment, etc.) Manages the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members Assures the proper timelines of the assigned projects Manages the budget of the project Plans and monitors the tasks of the team in the specific areas Collaborates with the Clinical Trial Administrators (CTAs) and CRAs in terms of local authorities approval activities Delivers project specific trainings / Organizes and participates in Monitor’s and Investigator’s Meetings

Senior Clinical Research Associate

• Jan 2021 - Sep 2022

Lead PM Team member

• Apr 2019 - Dec 2020

Working with the lead PM team at lead CRO for international multicenter Clinical Trial. - direct weekly contact with Sponsor - coordinating Submissions internationally - coordinating PM teams and CRAs of other countries - Investigator Meetings - Initiation Visits and Training of Profs and Site personnel - Coordinating IMP shipments - Coordinating Lab sample shipments - TMF / audit preparation - Translations reviewer (English, German, Greek, French) - Vendors… Show more Working with the lead PM team at lead CRO for international multicenter Clinical Trial. - direct weekly contact with Sponsor - coordinating Submissions internationally - coordinating PM teams and CRAs of other countries - Investigator Meetings - Initiation Visits and Training of Profs and Site personnel - Coordinating IMP shipments - Coordinating Lab sample shipments - TMF / audit preparation - Translations reviewer (English, German, Greek, French) - Vendors coordination Show less Working with the lead PM team at lead CRO for international multicenter Clinical Trial. - direct weekly contact with Sponsor - coordinating Submissions internationally - coordinating PM teams and CRAs of other countries - Investigator Meetings - Initiation Visits and Training of Profs and Site personnel - Coordinating IMP shipments - Coordinating Lab sample shipments - TMF / audit preparation - Translations reviewer (English, German, Greek, French) - Vendors… Show more Working with the lead PM team at lead CRO for international multicenter Clinical Trial. - direct weekly contact with Sponsor - coordinating Submissions internationally - coordinating PM teams and CRAs of other countries - Investigator Meetings - Initiation Visits and Training of Profs and Site personnel - Coordinating IMP shipments - Coordinating Lab sample shipments - TMF / audit preparation - Translations reviewer (English, German, Greek, French) - Vendors coordination Show less

Regional Project Manager (DACH)

• Jun 2018 - Dec 2019

START UP PHASE: Site Selection and Feasibility PSSVs SUBMISSIONS to CAs and IECs/IRBs Regulatory Plan Responsible for keeping Study Timelines PLANS OF THE STUDY Communication Plan Monitoring Plan Safety Plan CONTRACTS between Sponsor and Hospitals PROTOCOL presentations TRANSLATIONS (DE, GB, FR) WITH SPONSOR: Reports on Study Management, Study Status Budget Management (Vendors, Team, Office costs and Site payments) TMF Flow of Documents… Show more START UP PHASE: Site Selection and Feasibility PSSVs SUBMISSIONS to CAs and IECs/IRBs Regulatory Plan Responsible for keeping Study Timelines PLANS OF THE STUDY Communication Plan Monitoring Plan Safety Plan CONTRACTS between Sponsor and Hospitals PROTOCOL presentations TRANSLATIONS (DE, GB, FR) WITH SPONSOR: Reports on Study Management, Study Status Budget Management (Vendors, Team, Office costs and Site payments) TMF Flow of Documents and Delivery to Sponsor Responsible for Study Databank (Administration, Filing, COMMUNICATION WITH KEY ROLE PLAYERS Principal Investigators, LKP/ Lead of clinical trial in Germany TRAININGS OF TEAMS Show less START UP PHASE: Site Selection and Feasibility PSSVs SUBMISSIONS to CAs and IECs/IRBs Regulatory Plan Responsible for keeping Study Timelines PLANS OF THE STUDY Communication Plan Monitoring Plan Safety Plan CONTRACTS between Sponsor and Hospitals PROTOCOL presentations TRANSLATIONS (DE, GB, FR) WITH SPONSOR: Reports on Study Management, Study Status Budget Management (Vendors, Team, Office costs and Site payments) TMF Flow of Documents… Show more START UP PHASE: Site Selection and Feasibility PSSVs SUBMISSIONS to CAs and IECs/IRBs Regulatory Plan Responsible for keeping Study Timelines PLANS OF THE STUDY Communication Plan Monitoring Plan Safety Plan CONTRACTS between Sponsor and Hospitals PROTOCOL presentations TRANSLATIONS (DE, GB, FR) WITH SPONSOR: Reports on Study Management, Study Status Budget Management (Vendors, Team, Office costs and Site payments) TMF Flow of Documents and Delivery to Sponsor Responsible for Study Databank (Administration, Filing, COMMUNICATION WITH KEY ROLE PLAYERS Principal Investigators, LKP/ Lead of clinical trial in Germany TRAININGS OF TEAMS Show less

Clinical Research Associate

• Jul 2015 - Jun 2018

SITE MANAGEMENT in DE, CH, AT, UK. IMP & IMD Studies and NIS - All Phases Office and Field Based / remotely From Study Start up to Site Closure: 1. Contact new Sites, Feasibility, Pre-Selection-Site-Visits, Site Selection 2. Organization of Investigators meetings. 3. Submissions/Notifications/ Reports to ECs and Regulatory authorities 4. PROJECT MANAGEMENT Assistance: Essential study documents creation, Filing eTMF, pTMF, CTMS, Review and… Show more SITE MANAGEMENT in DE, CH, AT, UK. IMP & IMD Studies and NIS - All Phases Office and Field Based / remotely From Study Start up to Site Closure: 1. Contact new Sites, Feasibility, Pre-Selection-Site-Visits, Site Selection 2. Organization of Investigators meetings. 3. Submissions/Notifications/ Reports to ECs and Regulatory authorities 4. PROJECT MANAGEMENT Assistance: Essential study documents creation, Filing eTMF, pTMF, CTMS, Review and Tracking, TMF Delivery to Sponsor. 5. MONITORING: ICF Check, eCRF, Drug Accountability, Safety Review, SDV, eReports, Training and Advising Proffessors and Hospital Teams 6. Preparation of Sites for Audits/ Inspections 7. Administration of Shipment of Study Materials and IMP 8. Site Honorars/ Budget Show less SITE MANAGEMENT in DE, CH, AT, UK. IMP & IMD Studies and NIS - All Phases Office and Field Based / remotely From Study Start up to Site Closure: 1. Contact new Sites, Feasibility, Pre-Selection-Site-Visits, Site Selection 2. Organization of Investigators meetings. 3. Submissions/Notifications/ Reports to ECs and Regulatory authorities 4. PROJECT MANAGEMENT Assistance: Essential study documents creation, Filing eTMF, pTMF, CTMS, Review and… Show more SITE MANAGEMENT in DE, CH, AT, UK. IMP & IMD Studies and NIS - All Phases Office and Field Based / remotely From Study Start up to Site Closure: 1. Contact new Sites, Feasibility, Pre-Selection-Site-Visits, Site Selection 2. Organization of Investigators meetings. 3. Submissions/Notifications/ Reports to ECs and Regulatory authorities 4. PROJECT MANAGEMENT Assistance: Essential study documents creation, Filing eTMF, pTMF, CTMS, Review and Tracking, TMF Delivery to Sponsor. 5. MONITORING: ICF Check, eCRF, Drug Accountability, Safety Review, SDV, eReports, Training and Advising Proffessors and Hospital Teams 6. Preparation of Sites for Audits/ Inspections 7. Administration of Shipment of Study Materials and IMP 8. Site Honorars/ Budget Show less

CRA Assistant

• Jul 2014 - Jan 2015

CRA office based tasks Start up team - Submissions to EC, BfArM, PEI, BfS. CRA office based tasks Start up team - Submissions to EC, BfArM, PEI, BfS.

Clinical Studies Coordinator

• Dec 2011 - Dec 2013

CARDIAC SURGERY Coordination of several Study Teams Submissions to Ethic Committee Contracts Management - Collaboration with Hospital Clinical Studies Office. Budget Management per Study Project Patient’s Enrollment and Follow-Up Visits Randomisation and IMP / IMD Accountability Paper and Electronic CRFs, Reply to Queries, (S)AEs description and report Data Management (Patient Visits Documentation, SAP data, medical letters) Quality of Process (Internal… Show more CARDIAC SURGERY Coordination of several Study Teams Submissions to Ethic Committee Contracts Management - Collaboration with Hospital Clinical Studies Office. Budget Management per Study Project Patient’s Enrollment and Follow-Up Visits Randomisation and IMP / IMD Accountability Paper and Electronic CRFs, Reply to Queries, (S)AEs description and report Data Management (Patient Visits Documentation, SAP data, medical letters) Quality of Process (Internal Monitoring according to ICH-GCP) and SOPs Site’s Representative for Sponsors, PMs, CROs, CRAs Data Validation and Preparation of Publications Show less CARDIAC SURGERY Coordination of several Study Teams Submissions to Ethic Committee Contracts Management - Collaboration with Hospital Clinical Studies Office. Budget Management per Study Project Patient’s Enrollment and Follow-Up Visits Randomisation and IMP / IMD Accountability Paper and Electronic CRFs, Reply to Queries, (S)AEs description and report Data Management (Patient Visits Documentation, SAP data, medical letters) Quality of Process (Internal… Show more CARDIAC SURGERY Coordination of several Study Teams Submissions to Ethic Committee Contracts Management - Collaboration with Hospital Clinical Studies Office. Budget Management per Study Project Patient’s Enrollment and Follow-Up Visits Randomisation and IMP / IMD Accountability Paper and Electronic CRFs, Reply to Queries, (S)AEs description and report Data Management (Patient Visits Documentation, SAP data, medical letters) Quality of Process (Internal Monitoring according to ICH-GCP) and SOPs Site’s Representative for Sponsors, PMs, CROs, CRAs Data Validation and Preparation of Publications Show less

Research Associate

• 2009 - 2010

Klinik und Poliklinik für Psychiatrie und Psychotherapie. Research field : Biomarkers: Neurology / Alzheimer´s Disease / Cognitive Impairments Klinik und Poliklinik für Psychiatrie und Psychotherapie. Research field : Biomarkers: Neurology / Alzheimer´s Disease / Cognitive Impairments

Post-doctorate researcher and Stipendiatin

• 2002 - 2009

MPI for PSYCHIATRY. Research field: Depression / Stress / Neurodegeneration MPI for PSYCHIATRY. Research field: Depression / Stress / Neurodegeneration