freiberufler CLINICAL TRIAL BUSINESS EXPERT auf freelance.de

CLINICAL TRIAL BUSINESS EXPERT

zuletzt online vor wenigen Tagen
  • auf Anfrage
  • 40764 Langenfeld (Rheinland)
  • Weltweit
  • de  |  en
  • 17.10.2018

Kurzvorstellung

13 yrs EXPERTISE CLINICAL DEVELOPMENT, Trial Management I-IV, Operational Team Lead (international), Project Management, Site Management, TMF/Clinical Document Management, Spectrum of different indications.

Ich biete

  • Klinische Monitor (CRA)
  • Klinische Studie
  • Projekt-Dokumentation
  • Projektmanagement
  • Qualitätsmanagement (allg.)

Projekt‐ & Berufserfahrung

TMF Manager (Festanstellung)
UCB Biosciences, Rheinland
8/2015 – 8/2017 (2 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

8/2015 – 8/2017

Tätigkeitsbeschreibung

Strategic oversight of all global Trial Master File related operations
• Ensuring inspection readiness and Sponsor oversight; development and implementation of quality metrics and QC check guidelines
• Process improvement strategies; overseeing the migration of all studies into one single eTMF management system (Veeva)
• Development & maintenance of TMF SOP, TMF Plan and related business processes
• Manage vendor relationships including CROs in- and outside of the strategic partnering initiative (SPI), eTMF vendors
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Overseeing archiving and off-site storage of study-related documents at Iron Mountain
• eTMF system training oversight
• Mentoring of TMF Managers and TMF Assistants
• Speaker at the European Trial Master File Congress, 09/2016
• Member of the “Site Leadership Team”
• Member of the “Creative Lab”

Eingesetzte Qualifikationen

Pharmaforschung

Associate Clinical Project Manager (Festanstellung)
UCB Biosciences, Rheinland
1/2011 – 7/2015 (4 Jahre, 7 Monate)
Life Sciences
Tätigkeitszeitraum

1/2011 – 7/2015

Tätigkeitsbeschreibung

Planning and conducting clinical trials as Associate Clinical Project Manager
• Implementation of SPI within UCB: streamlining of processes and SOPs with different strategic partners; SOP simplification initiative
• Spot award “silver” for extraordinary contribution to the company by the implementation of SPI
• Implementation of clinical trials from setup to clinical study report
• First contact person for CROs within and outside the scope of SPI
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Strategic oversight of the entire operational study business
• Global coordination of the clinical site management
• Monitor- and site assessment visit
• Mentoring and training of (lead) CRAs
• Implementation of study requirements within the team, performance and quality control incl. CAPA management
• Ensuring Trial Master File maintenance by (SPI) partners, Sponsor oversight by performing regular QC checks and ensuring inspection readiness at all times
• Member of the “Site Leadership Team”
• Member of the “Creative Lab”

Eingesetzte Qualifikationen

Projektmanagement

Lead CRA
UCB Biosciences, Global
1/2011 – 12/2011 (1 Jahr)
Gesundheitswesen
Tätigkeitszeitraum

1/2011 – 12/2011

Tätigkeitsbeschreibung

Operational team lead (Lead CRA) of an international CRA team
• Successful conduct of a license-relevant phase I study
• Spot award “gold” for extraordinary contribution to the company by regaining U.S market authorization for one product
• Contact person for project management
• Global Trial Master File Management
• Ensuring inspection readiness of the Trial Master File
• Coordination of study-related submissions to Ethics Committees (ECs) and competent authorities
• Implementation of study requirements within the team, performance and quality control
• Monitor and site assessment visits
• Co-monitoring and monitoring report review
• Mentoring of CRAs
• Training of CRAs and site personnel

Eingesetzte Qualifikationen

Klinische Monitor (CRA)

Clinical Site Manager (CRA)
UCB Biosciences, Europa
1/2008 – 1/2011 (3 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

1/2008 – 1/2011

Tätigkeitsbeschreibung

As Clinical Site Manager responsible for monitoring and management of assigned investigative trial sites
• Blinded and unblinded monitoring of global, national, interventional and non-interventional clinical trials
• Contact person for investigators and study nurses
• Site selection, initiation, monitoring and close out
• Training of site personnel during international investigator meetings and site initiation visits
• Submission of study documents to ethics committees and competent authorities
• Close cooperation with other departments, e.g. Medical Affairs, CQA, Drug Safety, O&C, Regulatory, CTS, CTRRD
• Quality assurance and ensuring site compliance with all relevant laws, guidelines and regulations
• Site contract and budget negotiations
• Trial Master File maintenance
UCB Biosciences GmbH, Monheim
Department: Global Clinical Project Management
Clinical Trial Assistant

Eingesetzte Qualifikationen

Klinische Monitor (CRA)

Clinical Trial Assistant
Diverse, Rheinland
6/2004 – 1/2008 (3 Jahre, 8 Monate)
Life Sciences
Tätigkeitszeitraum

6/2004 – 1/2008

Tätigkeitsbeschreibung

Support of Project Management in all aspects of clinical trials

Eingesetzte Qualifikationen

Klinische Monitor (CRA)

Zertifikate

Veeva Vault Vertified Administrator
Oktober 2017

Ausbildung

NLP Master (Coaching)
(Ausbildung)
Jahr: 2013
Ort: Düsseldorf
NLP Practitioner (Coaching)
(Ausbildung)
Jahr: 2012
Ort: Düsseldorf
Biologie
(Diplom)
Jahr: 2003
Ort: Münster

Qualifikationen

I am a clinical trial professional with 13+ years experience in study management (phase I-IV), including positions as a Trial Master File Manager, Clinical Project Manager & (Lead) Clinical Site Manager (CRA).
Indications include Parkinson's disease, epilepsy, narcolepsy, restless legs syndrome, neuropathic pain, fibromyalgia, rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus, malignant melanoma, skin cancer.

Über mich

I am a strategically thinking, open-minded team player with a distinct attention to quality. I love fostering a constructive team spirit and communicate in an open and transparent manner, balancing the needs, resources, and personal and professional skills of involved project team members and stakeholders. Curious? Find out more by exploring my website.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
1245
Alter
43
Berufserfahrung
17 Jahre und 6 Monate (seit 06/2004)
Projektleitung
7 Jahre

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