Erfahrene Projektmanagerin und klinische Monitoring für internationale klinische Studien.
Aktualisiert am 30.01.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.02.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Projektmanagement
Regulatory Affairs
ICH- GCP
Monitoring
German
Mother tongue
Ladino
Mother tongue
English
Proficient
Italian
Proficient

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

5 Monate
2023-09 - 2024-01

Support development of medical plan in accordance to defined timelines

Manager Medical Operations
Manager Medical Operations
  • Support development of medical plan in accordance to defined timelines
  • Coordination and preparation of business reviews for all therapeutic areas in medical affairs
  • Overall management and controlling of country annual medical operating plan and respective spending
  • Management of insight reports and KPI
Alexion Pharma Germany, AstraZeneca
Munich, Germany
2 Jahre 8 Monate
2020-11 - 2023-06

Ensuring project progress and reaching of milestones/deliverables and KPI

Project Director
Project Director

Therapeutic area: Cardiology / International, Controlled Clinical Trial, phase III b (IMP in patients with cardiac device), 250 study sites

  • Ensuring project progress and reaching of milestones/deliverables and KPI
  • Status reporting to sponsor and general management throughout all phases of trial
  • Coordination of monitoring activities and quality control, including review of monitoring visit reports and risk assessment across all sites in Europe
  • Adaptation of Risk Based Monitoring Plan based on project development / requirements
  • Supervision of IMP vendor management and distribution to study sites
  • Budgeting: Creation of cost proposal for sponsor as well as budget oversight / adaptation of project budget based on project requirements
  • Coordination of billing to sponsor, verification of incoming and outgoing invoices including payment to study sites
  • Preparation of and participation in scientific committee meetings (KOL)
  • Pharmacovigilance: Adverse event (AE) / Serious Adverse Event (SAE) management, safety assessment and creation of yearly safety report (DSUR)
  • Leadership of project team: mentoring, training, quality control, billing of contingent workers

CRI ? The Clinical Research Institute GmbH
Munich, Germany
2 Jahre 10 Monate
2018-02 - 2020-11

Coordination and quality control of centralized and remote monitoring activities

Project Manager / Lead CRA
Project Manager / Lead CRA

Therapeutic area: Cardiology / International, Controlled Clinical Trial, phase III b (IMP in patients with cardiac device), 250 study sites

  • Coordination and quality control of centralized and remote monitoring activities including training and development of company and freelance CRAs, participation in co-visits
  • Preparation of and participation in site inspection by local authority as well as post-processing
  • Creation and revision of study-specific documents e.g. protocol amendments, patient information and consent forms, in collaboration with CRI?s regulatory affairs department according to SOP
  • Selection and acquisition of study sites, contract negotiation with study sites
  • Study site risk assessment, creation of action plan and escalation
  • Creation and revision of eCRF including user acceptance testing (UAT)
  • Pharmacovigilance: AE/ SAE management, coordination of Endpoint Review Committee (ERC)

CRI ? The Clinical Research Institute GmbH
Munich, Germany
2 Jahre 1 Monat
2016-01 - 2018-01

Performance of initiation, monitoring, close out

Clinical Research Professional
Clinical Research Professional

Therapeutic area: Cardiology, phase IV (IMP) / Therapeutic area: Cardiology, phase III b (IMP in patients with cardiac device)

  • Performance of initiation (~ 60), monitoring (~ 100), close out and motivational visits across Europe
  • Source data verification, identification of protocol and ICH-GCP violations
  • Creation of monitoring visit reports, documentation and resolution of quality issues at study sites
  • Primary point for contact for study sites, assisting and training of study teams
  • Set-up of new study sites, including collection of essential documents
  • Assisting Regulatory Affairs with submission to Ethics Committees and Competent Authority
  • Pharmacovigilance: AE/ SAE management

CRI ? The Clinical Research Institute GmbH
Munich, Germany
6 Monate
2015-07 - 2015-12

Performance of monitoring visits and site management

Clinical Research Associate
Clinical Research Associate

Therapeutic area: Oncology, phase III (IMP) / Therapeutic area: Neurology, phase III (IMP)

  • Primary point of contact for assigned study sites
  • Performance of monitoring visits and site management of German study sites
  • Source data verification, identification of protocol and ICH-GCP violations
  • Creation of monitoring visit reports, documentation and resolution of quality issues at study sites

Quintiles GmbH
Sauerlach, Germany
8 Monate
2014-11 - 2015-06

Review of reported SAE

Project Assistant
Project Assistant

Therapeutic area: Cardiology, phase IV (Medical Device ? adaptive servo ventilation in HF patients)

  • Review of reported SAE for plausibility, completeness and data compliance, in-house source data verification
  • Preparation of Endpoint Review Committee meetings
  • Assistance to study sites for resolution of issues
  • Verification and documentation of essential documents

CRI ? The Clinical Research Institute GmbH
Munich, Germany
4 Monate
2013-12 - 2014-03

Internships

  • Patient assessment and creation of treatment plan
  • Documentation of medical history and therapeutic progress
  • Administrative duties e.g. arranging appointments, answering phone calls
  • Optimise the practice?s workflow
Serlas Physiotherapie
S-Chanf, Switzerland
5 Monate
2013-08 - 2013-12

Internships

  • Patient assessment and creation of treatment plan
  • Documentation of medical history and therapeutic progress
  • Administrative duties e.g. arranging appointments, answering phone calls
  • Optimise the practice?s workflow
ATOS Klinik
Munich
2 Monate
2011-04 - 2011-05

Internships

  • Patient assessment and creation of treatment plan
  • Documentation of medical history and therapeutic progress
  • Administrative duties e.g. arranging appointments, answering phone calls
  • Optimise the practice?s workflow
John Allen Physiotherapy ? Rehabilitation Sports Medicine
London, United Kingdom

Aus- und Weiterbildung

2 Monate
2023-07 - 2023-08

Drug Commercialization

University College San Diego, online course
University College San Diego, online course
4 Monate
2017-09 - 2017-12

IHK Projekt Manager

IHK Akademie, Weilheim, Germany
IHK Akademie, Weilheim, Germany
4 Jahre
2010-08 - 2014-07

Bachelor in Physiotherapy

Bachelor?s Degree in Physiotherapy, Fontys University of Applied Sciences, Eindhoven, The Netherlands
Bachelor?s Degree in Physiotherapy
Fontys University of Applied Sciences, Eindhoven, The Netherlands
Bachelor Thesis: ?For adult patients suffering from HIV/AIDS is Mindfulness Based Stress Reduction an effective adjuvant treatment option to improve immune function and psychological well-being? A Literature Research?
4 Jahre 11 Monate
2004-09 - 2009-07

High-school

High-school diploma with focus on science-related subjects, Wissenschatliches Lyzeum Peter Anich, Bolzano, Italy
High-school diploma with focus on science-related subjects
Wissenschatliches Lyzeum Peter Anich, Bolzano, Italy
10 Monate
2007-09 - 2008-06

A-levels diploma in modern languages

A-levels diploma in modern languages (English, Italian, German) and science, Bournemouth & Poole College, Bournemouth, United Kingdom
A-levels diploma in modern languages (English, Italian, German) and science
Bournemouth & Poole College, Bournemouth, United Kingdom

Kompetenzen

Top-Skills

Projektmanagement Regulatory Affairs ICH- GCP Monitoring

Produkte / Standards / Erfahrungen / Methoden

Summary

8 Years

Role: Clinical Research Associate

Customer: Cardiology, Oncology, Neurology


Tasks:

  • Monitoring visits: Conduction of initiation, monitoring, close out and motivational visits in 14 European countries
  • Study documents: Compile and ensure completeness of study and regulatory documents
  • Compliance: Ensure protocol, regulatory and ICH-GCP requirements are met
  • Risk assessment: Identification of protocol and GCP violation, implementation of corrective and preventive actions
  • Site Inspection Readiness: Preparation, participation and follow-up of site inspections
  • Site management: site selection, contract negotiations and site training
  • Regulatory submission: Submission of study sites and protocol amendments to EC and CA

5 Years

Role: Clinical Trial Manager

Customer: Cardiology


Tasks:

  • Project oversight:
    • Ensure study performance according to ICH-GCP, identification of deviations or risks
    • Control and coordination of study timelines, milestones and deliverables
    • Coordination and management of vendors
    • Project budgeting
  • Study documents: Development and review of study documents according to SOP
  • Monitoring activities:
    • Coordination of CRAs and monitoring visits in 18 European countries
    • Coordination and management of collaborating CROs
    • Coordination of site inspections
  • Quality management
    • Review and evaluation of monitoring visit reports
    • Development of site risk assessment tool
    • Continuous review of study management and conduct according to SOP and GCP
    • Review of ongoing and final study data


Personal characteristics

Strong work ethic | detail oriented | solution focused | reliable | responsible | flexible | well organised

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