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Regulatory Affairs and Start-up Specialist

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  • auf Anfrage
  • Bayern
  • Europa
  • de  |  en  |  fr
  • 16.10.2024

Kurzvorstellung

- Cover all Submission and Start-up activities for Clinical Studies, all phases.
- Negotiate site budget and contracting in the given time frame.
- Medical Device Life Cycle Programm Manager,
- CRA Lead
- Pioneer and Founder

Qualifikationen

  • Gute Klinische Praxis8 J.
  • Pharmazie
  • Softwaredokumentation1 J.

Projekt‐ & Berufserfahrung

Regulatory Affairs Study Start-up Specialist (Festanstellung)
CTI Clinical Trial and Consulting Services, Ulm
11/2023 – 9/2024 (11 Monate)
Life Sciences
Tätigkeitszeitraum

11/2023 – 9/2024

Tätigkeitsbeschreibung

-Perform submission (IRB, EC, CA) and other Regulatory Bodies on behalf of sponsors.
- Compile Regulatory documentation according to the SOP's and applicable country requirements, perform QC checks.
- Adapt Informed Consent Form (ICF) according to the IRB/EC requests on country or site level. (DE, ES and FR)

Eingesetzte Qualifikationen

Gute Klinische Praxis, Softwaredokumentation

Contract- and Budget Specialist; D A CH
Eli Lilly Cork Limited, Cork, Ireland
3/2022 – 10/2023 (1 Jahr, 8 Monate)
Biotechnology
Tätigkeitszeitraum

3/2022 – 10/2023

Tätigkeitsbeschreibung

- Site contracting study start-up phase, focus oncology studies.
- Develop process documentation.
- Developing study specific contracting and budgeting strategy with the internal stakeholders
- Primary contact and process owner for interactions between TC and Lilly US, Legal / Finance related to process changes, documentation requirements, and site contracting and budgeting issues.
- Development and realization of terms and provisions for country specific templates (implementation of EU 536/2014).
- Supporting, adapting and submission of relevant study documentation for CTIS submission (Part I and Part II) for DE and AT.
- Adaptation and revision of ICFs, SOPs and eTMF specifications to EU No. 536/2014.
- Contracting in compliance with planned enrolment timelines (90%).
- Mentoring and training of new hires.

Eingesetzte Qualifikationen

Projektdurchführung

Interim Clinical Operations Manager
Sigal SMS, SMO, Leipzig
7/2021 – 2/2022 (8 Monate)
Life Sciences
Tätigkeitszeitraum

7/2021 – 2/2022

Tätigkeitsbeschreibung

-Managing of the feasibility process, recruitment support and strategies, study project management,
- Set-up of study budgets, negotiations - and contracting,
- Line - management function,
This role was limited as a parental leave replacement

Eingesetzte Qualifikationen

Gute Klinische Praxis

Sen. Associate Investigator Sponsored Studies
AMGEN GmbH, Munich, München
12/2015 – 9/2020 (4 Jahre, 10 Monate)
Life Sciences
Tätigkeitszeitraum

12/2015 – 9/2020

Tätigkeitsbeschreibung

Sole responsibility for managing the none-AMGEN sponsored clinical Trials (28 ISS projects, all study phases, Oncology).
Fair Market Value Assessment, Financial project management.

Eingesetzte Qualifikationen

Gute Klinische Praxis, Projekt - Berichtswesen

Clinical Quality Assurance Manager (Festanstellung)
Hexal AG, Holzkirchen
6/2014 – 12/2015 (1 Jahr, 7 Monate)
Life Sciences
Tätigkeitszeitraum

6/2014 – 12/2015

Tätigkeitsbeschreibung

Inspection preparation for Audit and FDA Inspection;
General support of Inspection Manager, e.g. development of trackers and overview, meeting organization, collection of information, Share Point set -up. Interaction with Health Authorities.
Releasing of Standard Operating Procedures (SOP)
and Global – SOP’s.
Creating and set-up the internal approval process for SOP’s.

Eingesetzte Qualifikationen

Gute Klinische Praxis

Zertifikate

ICH-GCP Training
Pharma Industry
2023

Ausbildung

Leiter Klinische Studien nach MPG
Ausbildung
BÄK
2019
International Marketing and Controlling
M.A.
College of Villingen-Schwenningen
1987
Villingen-Schwenningen

Weitere Kenntnisse

 Veeva Vault EDC, VAULT Clinical (Managing clinical Studies)
 SIP, SIP DocX Application, CTMS
 Informed Consent Form (ICF – Trainings)
 Quality Management (Deviation, CAPA, Root-Cause Analysis)
 Manage Trial Submission under the EU Clinical Trial Regulation
 Trial Design and Allocate Countries, Sites & Study Participants.
 Recruitment and Retention Strategies in clinical Trials
 ICH- GCP based on CTR 536/2014
 MPG; Study Lead
 German Society of Anti-Aging Medicine: Anti-Aging Consultant
 All MS Office Applications,
 Sales Force Applications

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
71
Berufserfahrung
14 Jahre und 9 Monate (seit 01/2010)
Projektleitung
5 Jahre

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