freiberufler Senior Clinical Program Lead auf freelance.de

Senior Clinical Program Lead

zuletzt online vor 5 Tagen
  • 80‐220€/Stunde
  • 81545 München
  • auf Anfrage
  • de  |  en  |  es
  • 08.08.2022

Kurzvorstellung

I have deept knowlegde of the conduction and organization of clinical trials according to national and international guidelines.

Ich biete

  • Klinische Monitor (CRA)
  • Klinische Studie
  • Medizinforschung
  • Pharmaforschung
  • Projektmanagement
  • Regulatory Affairs Management
  • SQL

Projekt‐ & Berufserfahrung

Senior Clinical Program Lead (SCPL) (Festanstellung)
Foundation Medicine GmbH, Penzberg
10/2020 – 5/2022 (1 Jahr, 8 Monate)
Gesundheitswesen
Tätigkeitszeitraum

10/2020 – 5/2022

Tätigkeitsbeschreibung

The SCPL in Clinical Operations and Data Management tasks are:
• Provides comprehensive operational support for FMI’s
participation in clinical trials sponsored by BioPharma partners,
Academic partners, and FMI led trials
• Manage strategically a portfolio of studies independently and
efficiently
• Developing, implementing, and monitoring the execution plans
for the clinical studies they support from initial study intake
through final project deliverables
• contributing to the design of partner and FMI sponsored
research
• Proactive, clear, and customer-centric communication, day to
day project management, as well as, operational excellence
and oversight of clinical trials.
• Work collaboratively with internal and external stakeholders
across functions to manage samples, timelines, resource
plans, and critical path activities directly impacting the
successful implementation and on-going execution of clinical
studies.

Eingesetzte Qualifikationen

Programm Management

International Clinicial Operations Lead (Festanstellung)
Servier Forschung GmbH, Munich
10/2019 – 9/2020 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

10/2019 – 9/2020

Tätigkeitsbeschreibung

Lead of a International Clinical Operations Management Team on clinical trials including:
• Actively participates in Study Team meetings, providing up-to-date and concise information on study progress from the clinical operations perspective, identifying important field operations issues that require input from the Team and proposing solutions
• Proactive and close liaison between the field activities in different countries participating studies, consolidating and disseminating important information to international study personnel and the Study Team in a timely manner to guarantee an even level of project relevant knowledge
• At international level, coordinates, oversees and report on the local/regional Clinical Operations Project Managers (COPM) to ensure that study-related activities are conducted according to expected quality, timelines and budget
• Ensure the International Clinical Operations personnel are adequately trained and provide trainings when required
• Lead the execution of the country and center feasibility and consolidates the results/feedback to the Study Team
• Identify in close collaboration with the Study Team leader an appropriate monitoring strategy, develops the Monitoring Plan with input from COPMs, for in-house and outsourced monitoring choices
• Oversee patient recruitment and retention during the study and when necessary, pro-actively works with COPMs to develop and propose action plans to the study team
• Track the quality of the data (Deviations, CAPAs, etc.) and when relevant, report important issues to the Study Team
• Manages the outsourcing to international monitoring CROs (for multi-country studies), including participating in the selection and management of the CRO
• Assists in the preparation of tools and logistic of the study
• Ensure that all necessary study documentation is gathered and correctly stored in the study master file

Eingesetzte Qualifikationen

Pharmaforschung

Zertifikate

Clinical Research Associate
März 2012

Ausbildung

Medizinischen Dokumentar
(Ausbildung)
Jahr: 2009
Ort: Ulm

Über mich

Engagierter Projektmanager mit Erfahrung bei der Planung und Durchführung von klinischen Studien,

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Spanisch (Grundkenntnisse)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
6
Alter
36
Berufserfahrung
12 Jahre und 10 Monate (seit 10/2009)
Projektleitung
5 Jahre

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