freiberufler Clinical Trial Management / Sponsor Oversight / TMF Management auf freelance.de

Clinical Trial Management / Sponsor Oversight / TMF Management

zuletzt online vor 2 Tagen
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  • 52134 Herzogenrath
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  • de  |  en
  • 13.03.2024

Kurzvorstellung

More than 20 years of experience in clinical trial management of international trials phase I-IV including project management, sponsor oversight, SOP development and TMF management.

Qualifikationen

  • Clinical Trial Management
  • Document Management
  • Dokumentenmanagement
  • Good clinical practice (GCP)
  • Good documentation practice (GDP, GDocP)
  • Klinische Studie
  • Projekt-Dokumentation
  • Projektdurchführung
  • Projektmanagement
  • Sponsor Oversight
  • Trial Master File

Projekt‐ & Berufserfahrung

Lecturer
FORUM Institut für Management GmbH, remote
11/2023 – offen (5 Monate)
Further education
Tätigkeitszeitraum

11/2023 – offen

Tätigkeitsbeschreibung

Speaker in the training course 'electronic Trial Master File in clinical trials'

Eingesetzte Qualifikationen

Klinische Studie, Good clinical practice (GCP), Good documentation practice (GDP, GDocP), MS Office (Anwenderkenntnisse), MS PowerPoint, Projekt-Dokumentation, Archivierung, Dokumentenmanagement

Freelance Project Manager & TMF Manager
Kundenname anonymisiert, remote
3/2023 – offen (1 Jahr, 1 Monat)
CRO
Tätigkeitszeitraum

3/2023 – offen

Tätigkeitsbeschreibung

Project Management national Phase II trial and implementation of eTMF

Eingesetzte Qualifikationen

Dokumentenmanagement, Good clinical practice (GCP), Good documentation practice (GDP, GDocP), Klinische Studie, Projekt-Dokumentation, Projektdurchführung, Projektmanagement

Freelance Clinical Operations Lead
Kundenname anonymisiert, remote
11/2020 – 8/2022 (1 Jahr, 10 Monate)
Biotech
Tätigkeitszeitraum

11/2020 – 8/2022

Tätigkeitsbeschreibung

• Trial Team Lead / Sponsor Oversight for international phase II clinical trial (ophthalmology/ immunology)
• SOP authoring of trial management, sponsor oversight and informed consent SOPs
• eTMF Subject Matter Expert; supervision and performance control of eTMF set-up and maintenance for various clinical trials / CROs

Eingesetzte Qualifikationen

Good clinical practice (GCP), Klinische Studie, Projektmanagement

Senior Document Management Specialist (Festanstellung)
Grünenthal GmbH, Aachen
3/2018 – 10/2019 (1 Jahr, 8 Monate)
Pharma
Tätigkeitszeitraum

3/2018 – 10/2019

Tätigkeitsbeschreibung

• Implement eTMF including SOP authoring and training of users
• Maintain the process framework for TMF management and life-cycle management
• Support trial management teams in setting up, maintaining and archiving TMFs according to regulatory requirements using different business models (eTMF at Sponsor, eTMF at CRO, paper TMF at CRO)

Eingesetzte Qualifikationen

Good clinical practice (GCP), Klinische Studie

Clinical Trial Lead (Festanstellung)
Grünenthal GmbH, Aachen
9/2015 – 3/2018 (2 Jahre, 7 Monate)
Pharma
Tätigkeitszeitraum

9/2015 – 3/2018

Tätigkeitsbeschreibung

• Accountable for all aspects of assigned clinical trials (phase I and phase III) including successfully leading the trial management team
• As member of the working group: 'risk-based approach – tools and frameworks in clinical operations', development and implementation of a process and associated tools for a risk-based approach in clinical trial management and sponsor oversight
• Author of the SOP 'trial management and sponsor oversight of clinical trials', the sponsor oversight plan template and further supportive documents to this SOP as well as development of training materials and execution of classroom trainings

Eingesetzte Qualifikationen

Good clinical practice (GCP), Klinische Studie, Projektmanagement

Global Operations Study Manager (Festanstellung)
Grünenthal GmbH, Aachen
9/2013 – 9/2015 (2 Jahre, 1 Monat)
Pharma
Tätigkeitszeitraum

9/2013 – 9/2015

Tätigkeitsbeschreibung

• Responsible for providing operational support to study teams throughout all phases of clinical study management
• Ensure accordance with the appropriate quality standards including ICH/GCP as well as applicable regulations
• Giving support to the Global Operations Study Leader in designated management tasks

Eingesetzte Qualifikationen

Good clinical practice (GCP), Klinische Studie

Clinical Study Manager (Festanstellung)
Grünenthal GmbH, Aachen
4/2006 – 8/2013 (7 Jahre, 5 Monate)
Pharma
Tätigkeitszeitraum

4/2006 – 8/2013

Tätigkeitsbeschreibung

• Accountable for delivering effective and efficient early development clinical trials (including First in Man) of assigned medicinal product in accordance with appropriate quality standards including ICH/GCP and applicable regulations
• Provide operational expertise and leadership to the clinical operations team ensuring the efficient and effective delivery of all operational aspects of assigned clinical trials
• Ensure accordance with the appropriate quality standards including ICH/GCP and applicable regulations

Eingesetzte Qualifikationen

Good clinical practice (GCP), Klinische Studie, Projektmanagement

Local Trial Manager / Manager Clinical Research Switzerland (Festanstellung)
Johnson & Johnson Pharmaceutical R&D, division of, Neuss
9/2002 – 3/2006 (3 Jahre, 7 Monate)
Pharma
Tätigkeitszeitraum

9/2002 – 3/2006

Tätigkeitsbeschreibung

• Local trial management in Germany and Switzerland of international phase II and phase III trials as well as investigator-initiated trials
• Responsible person for all clinical trial activities in Switzerland
• Responsible for trial data quality and delivery of commitments regarding timelines and patient numbers
• Conducting country feasibilities
• Responsible for budget adherence
• Coordination of CRAs and Local Trial Managers
• Developing country specific SOPs and training of internal staff

Eingesetzte Qualifikationen

Good clinical practice (GCP), Klinische Studie, Projektmanagement

Clinical Research Associate (Festanstellung)
SKM Oncology Research GmbH, Nürnberg
2/2001 – 8/2002 (1 Jahr, 7 Monate)
CRO
Tätigkeitszeitraum

2/2001 – 8/2002

Tätigkeitsbeschreibung

• Monitoring of international and national oncological trials phase III
• Project management and CRA coordination of an international phase III trial

Eingesetzte Qualifikationen

Good clinical practice (GCP), Klinische Monitor (CRA), Klinische Studie

Ausbildung

Cell Biology
Ph.D.
2001
Bonn, Germany

Über mich

Brief Profile
• Systematic and goal-oriented planning and execution of clinical trials
• Motivation of multidisciplinary study teams via clear communication of expectations and a high level of enthusiasm
• Establishing best conditions for successful collaboration with external suppliers through effective contract design, clear communication of expectations and regular quality control
• Effective and result-oriented approach to the development of Standard Operating Procedures and the training of their users
• Increase productivity through implementation of new processes and systems with high quality awareness
• Optimal time management through fast reaction to changing conditions and requirements, always supporting the overall result

Weitere Kenntnisse

FURTHER EDUCATION
Conflict Management, 02-03 Nov & 07 Dec 2015, Inhouse Training by Anne de Neck
GCP Refresher Training, 05 Sep 2017 Inhouse Training by Prof. Barbara Sickmüller
Risk & Risk Management in Clinical Trials, 11 Oct 2018 by Tower Mains Training
Overview of ICH E6 R2, 29 Jan 2019 Inhouse Training by Andy Lawton
Risk Based Approach in Clinical Trials (including Risk Based Monitoring, Central Monitoring, Quality Tolerance Limits, Issue Management, Oversight, Quality by Design), 29-31 Jan 2019 by Andy Lawton
PhlexEview eTMF Super User and Admin User Training, 08-09 May & 12 June 2019 by Phlexglobal
GCP Refresher Training: focus on CRO/Vendor Oversight, 14-15 Feb 2022 by Laura Brown, Whitehall Training
EU Clinical Trial Regulation 536/2014 (CTR): Transitional Provisions and New Concepts, 30 Mar 2022 by Dagmar Chase, European CRO Federation

COMPUTER (USER) SKILLS:
Proficient MS-Office user
Project Management tools (MS Project, Unip)
Budget Planning tool
Electronic Trial Master File systems ((PhlexEview, SimpleTrials, NextDocs, Veeva Vault)
Document Management System (based on FirstDocs, M-Files)
Clinical Trial Management Systems
Central Safety Data Reporting System (Pharmasol)
Electronic Case Report Forms, Interactive Response Technology

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
auf Anfrage
Home-Office
bevorzugt
Profilaufrufe
492
Alter
50
Berufserfahrung
23 Jahre und 1 Monat (seit 02/2001)
Projektleitung
11 Jahre

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