Clinical project management
Aktualisiert am 07.11.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.12.2024
Verfügbar zu: 80%
davon vor Ort: 20%
Organizational skills
communication skills
Leading if cross-functional teams
project management
Intercultural communication
mentoring
Problemanalyse
Coaching
Trainer
Good Clinical Practice
Audit
Medical writing
German
Muttersprache
English
Verhandlungssicher
French
Grundkenntnisse

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

12 Jahre 6 Monate
2012-06 - heute

Clinical Research

Freelance Expert
Freelance Expert

  •  Hybrid with home-office in Berlin/Dortmund

1 Jahr 4 Monate
2023-03 - 2024-06

Ensuring compliance with regulatory requirements, timelines and budgets

Head of Monitoring / Project Management
Head of Monitoring / Project Management

  • Leading a team of Clinical Research Associates (CRAs) ensuring effective planning and delivery of clinical studies throughout phase II ? III and NIS.
  • Consulting project leaders in monitoring strategies including risk mitigation.
  • On-boarding and mentoring freelance new-hires to manage the fast changing workload of a mid-sized CRO.
  • Ensuring compliance with regulatory requirements, timelines and budgets.
  • Analysing processes and initiating improvements to enhance organizational effectiveness.

ClinCompetenceCologne GmbH
Cologne
9 Jahre 8 Monate
2014-10 - 2024-05

Negotiating and managing contracts for pre-clinical and clinical studies

CRO Manager
CRO Manager

  • Acting as a point of contact between internal teams and partners for study-related inquiries.
  • Negotiating and managing contracts for pre-clinical and clinical studies with external laboratories, contract research organizations (CROs), and research institutions.
  • Ensuring timely project execution and compliance with regulatory standards.
  • Fostering team motivation and interdisciplinary knowledge through internal training sessions.

Bayer AG
Berlin
2 Jahre
2010-06 - 2012-05

Quality Management

Training Specialist
Training Specialist

  • Delivering a 4-day live training program for all in-house and on-site roles in the EU clinical operations department.
  • Consulting project leaders and line managers with regard to training curriculums and quality issues in cross-functional international teams.
  • Quality assurance and corrective and preventative actions (CAPA) management.

Parexel International GmbH
Berlin
1 Jahr 5 Monate
2009-02 - 2010-06

Leading study start-up and on-site monitoring incl. mentoring of junior CRAs

Senior Clinical Research Associate
Senior Clinical Research Associate

  • Leading study start-up and on-site monitoring incl. mentoring of junior CRAs
  • Performing co-visits and streamlining the study start in Germany for a worldwide phase II trial.
  • Leading a team of clinical trial assistances for the final QA check of the TMF in a worldwide NIS.
  • Ensure regulatory compliance and support Audits and Inspections.

Parexel International GmbH
Berlin
1 Jahr 2 Monate
2007-11 - 2008-12

Project Management, on-site and in-house monitoring

Senior Clinical Research Associate
Senior Clinical Research Associate

  • Project Management, on-site and in-house monitoring (using EDC systems) for phase I-III neurological studies.
  • Training and supervision of in-house CRAs for a phase III neurological study.
  • Communication with regulatory authorities including initial regulatory submissions in Germany and Austria.

Cato Europe GmbH
Cologne
2 Jahre 1 Monat
2005-10 - 2007-10

Communication with regulatory authorities incl. submissions

Clinical Research Associate
Clinical Research Associate

  • Feasibility, study start-up, qualification, initiation, interim monitoring and closeout visits for a worldwide phase IIb study for patients with acute ischemic stroke.
  • Communication with regulatory authorities incl. submissions in Germany, Switzerland and Austria.
  • Writing and submitting Protocol Synopses, Amendments, Safety Reports and a Study Final Report. 

Studika GmbH / Cato Research Germany
Cologne

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2005-09 - 2005-09

Ph.D. in Biology (magna cum laude)

University Hospital of the RWTH-Aachen. Department of Neurology
University Hospital of the RWTH-Aachen. Department of Neurology
  • Thesis on request
1 Monat
2001-05 - 2001-05

Graduate degree in Biology (sehr gut)

RWTH-Aachen, Institute for Zoology/Animal Physiology
RWTH-Aachen, Institute for Zoology/Animal Physiology
  • Thesis on reqeust

Kompetenzen

Kompetenzen

Top-Skills

Organizational skills communication skills Leading if cross-functional teams project management Intercultural communication mentoring Problemanalyse Coaching Trainer Good Clinical Practice Audit Medical writing

Produkte / Standards / Erfahrungen / Methoden

PERSONAL PROFILE:
Highly motivated, trustworthy, customer-oriented and dedicated leader. Bringing a deep understanding of clinical trial processes and project management, with a strong emphasis on integrity and efficiency. Cultivating collaboration across teams and departments with outstanding communication skills, very good team working and organizational qualities through various national, European and international projects. Combining strong analytical skills, the ability to synthesize information, and present it clearly with an inspiring and motivating mentorship.

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

12 Jahre 6 Monate
2012-06 - heute

Clinical Research

Freelance Expert
Freelance Expert

  •  Hybrid with home-office in Berlin/Dortmund

1 Jahr 4 Monate
2023-03 - 2024-06

Ensuring compliance with regulatory requirements, timelines and budgets

Head of Monitoring / Project Management
Head of Monitoring / Project Management

  • Leading a team of Clinical Research Associates (CRAs) ensuring effective planning and delivery of clinical studies throughout phase II ? III and NIS.
  • Consulting project leaders in monitoring strategies including risk mitigation.
  • On-boarding and mentoring freelance new-hires to manage the fast changing workload of a mid-sized CRO.
  • Ensuring compliance with regulatory requirements, timelines and budgets.
  • Analysing processes and initiating improvements to enhance organizational effectiveness.

ClinCompetenceCologne GmbH
Cologne
9 Jahre 8 Monate
2014-10 - 2024-05

Negotiating and managing contracts for pre-clinical and clinical studies

CRO Manager
CRO Manager

  • Acting as a point of contact between internal teams and partners for study-related inquiries.
  • Negotiating and managing contracts for pre-clinical and clinical studies with external laboratories, contract research organizations (CROs), and research institutions.
  • Ensuring timely project execution and compliance with regulatory standards.
  • Fostering team motivation and interdisciplinary knowledge through internal training sessions.

Bayer AG
Berlin
2 Jahre
2010-06 - 2012-05

Quality Management

Training Specialist
Training Specialist

  • Delivering a 4-day live training program for all in-house and on-site roles in the EU clinical operations department.
  • Consulting project leaders and line managers with regard to training curriculums and quality issues in cross-functional international teams.
  • Quality assurance and corrective and preventative actions (CAPA) management.

Parexel International GmbH
Berlin
1 Jahr 5 Monate
2009-02 - 2010-06

Leading study start-up and on-site monitoring incl. mentoring of junior CRAs

Senior Clinical Research Associate
Senior Clinical Research Associate

  • Leading study start-up and on-site monitoring incl. mentoring of junior CRAs
  • Performing co-visits and streamlining the study start in Germany for a worldwide phase II trial.
  • Leading a team of clinical trial assistances for the final QA check of the TMF in a worldwide NIS.
  • Ensure regulatory compliance and support Audits and Inspections.

Parexel International GmbH
Berlin
1 Jahr 2 Monate
2007-11 - 2008-12

Project Management, on-site and in-house monitoring

Senior Clinical Research Associate
Senior Clinical Research Associate

  • Project Management, on-site and in-house monitoring (using EDC systems) for phase I-III neurological studies.
  • Training and supervision of in-house CRAs for a phase III neurological study.
  • Communication with regulatory authorities including initial regulatory submissions in Germany and Austria.

Cato Europe GmbH
Cologne
2 Jahre 1 Monat
2005-10 - 2007-10

Communication with regulatory authorities incl. submissions

Clinical Research Associate
Clinical Research Associate

  • Feasibility, study start-up, qualification, initiation, interim monitoring and closeout visits for a worldwide phase IIb study for patients with acute ischemic stroke.
  • Communication with regulatory authorities incl. submissions in Germany, Switzerland and Austria.
  • Writing and submitting Protocol Synopses, Amendments, Safety Reports and a Study Final Report. 

Studika GmbH / Cato Research Germany
Cologne

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2005-09 - 2005-09

Ph.D. in Biology (magna cum laude)

University Hospital of the RWTH-Aachen. Department of Neurology
University Hospital of the RWTH-Aachen. Department of Neurology
  • Thesis on request
1 Monat
2001-05 - 2001-05

Graduate degree in Biology (sehr gut)

RWTH-Aachen, Institute for Zoology/Animal Physiology
RWTH-Aachen, Institute for Zoology/Animal Physiology
  • Thesis on reqeust

Kompetenzen

Kompetenzen

Top-Skills

Organizational skills communication skills Leading if cross-functional teams project management Intercultural communication mentoring Problemanalyse Coaching Trainer Good Clinical Practice Audit Medical writing

Produkte / Standards / Erfahrungen / Methoden

PERSONAL PROFILE:
Highly motivated, trustworthy, customer-oriented and dedicated leader. Bringing a deep understanding of clinical trial processes and project management, with a strong emphasis on integrity and efficiency. Cultivating collaboration across teams and departments with outstanding communication skills, very good team working and organizational qualities through various national, European and international projects. Combining strong analytical skills, the ability to synthesize information, and present it clearly with an inspiring and motivating mentorship.

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