20 beste Stellen als documentation specialist in münchen – aktuell auf Personalsuche

Study Start Up Associate
Alira Health —München
- Vollzeit
- Microsoft Office
- Bachelor
Executive Project Management and Reporting Specialist (m/f/d) at Allianz SE
Allianz —München
- Vollzeit
- Informatik
- SQL
- Bachelor
Junior Quality Control Specialist - Incoming Inspection (all genders)
SKD SE —München
- Vollzeit
- Schemata
- ERP-Systeme
- Qualitätskontrolle
TECHNICAL SPECIALIST (M/F/D) – RADIO REMOTE CONTROL SYSTEMS
Flodraulic GmbH —Olching
- Vollzeit
- Schemata
- Baumaschinen
- Englisch
- Kostenloser Parkplatz
- Flexible Arbeitszeiten
Direkt bewerben
IT Support Specialist (m/f/d)
Ontime Courier GmbH —München
- Vollzeit
- Windows
- Bachelor
- Erfahrung mit Netzwerken
- Gleitzeit
- Flexible Arbeitszeiten
Customer Support Specialist (all genders)
Avelios Medical GmbH —München
- Vollzeit
- Flexible Arbeitszeiten
Quality Control Specialist (all genders)
SKD SE —München
- Vollzeit
- Microsoft Office
- Qualitätskontrolle
Pension & Benefits Specialist (m/w/d)
Haleon —München
- Vollzeit
- Microsoft Excel
- Master
- Bachelor
- Homeoffice-Möglichkeit
ESG Data Management Specialist (m/f/d) - (limited 12-15 months)
Allianz —München
- Vollzeit
- Microsoft Excel
- Finanzwirtschaft
- Finanzdienstleistungen
9 Tage
Support Specialist (MACE Audit) (f/m/d)
TÜV SÜD PS GmbH —München
- Vollzeit
Customer Support Specialist (all genders)
Avelios Medical —München
- Vollzeit
- Flexible Arbeitszeiten
Support Specialist (MACE Audit) (f/m/d)
TÜV SÜD —München
- Vollzeit
Technical Documentation Specialist – Railway Display and Audio Systems & Device Engineering (m/w/d)
Wabtec —München
- Vollzeit
- Hybrides Arbeiten
- Schemata
- CAD
- Microsoft Office
Direkt bewerben
Specialist, Programme Schedule Management, IRIS2
SES —München
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Building Maintenance Specialist
The Exploration Company —München
- 52.000 € – 70.000 € pro Jahr
- Vollzeit
- Doktorat
- Wartung
- HLK
- Umzugskostenzuschuss
Platform Integration - Senior Trading Technology Specialist (m/f/d)*
Munich Re —München
- Vollzeit
- Hybrides Arbeiten
- Java
- Agile
- Künstliche Intelligenz
Quality Specialist - Travel Claims
Allianz —Aschheim
- Vollzeit
- Microsoft Excel
Procurement & Supply Chain Specialist for Drones & Embedded Electronics
SE3 Labs —München
- Vollzeit
- Militär
- ERP-Systeme
- Mit Reiseanteil
IT Support Specialist
Helsing —München
- Windows
- Scripting
- SharePoint
Direkt bewerben
Senior Regulatory Affairs Specialist (m/w/d)
Dornier MedTech Systems GmbH —Weßling
- Vollzeit
- Englisch
- Microsoft Office
- Zeitmanagement
- Flexible Arbeitszeiten
Direkt bewerben

Ich möchte aktuelle Job-E-Mails für Stellen als documentation specialist in münchen erhalten

Wenn Sie sich bei Ihrem Konto anmelden, stimmen Sie den Nutzungsbedingungen, den Richtlinien zur Verwendung von Cookies sowie der Datenschutzerklärung von SimplyHired zu.

Weitere Job-Standorte erkunden

documentation specialist jobs near münchen

Study Start Up Associate

Alira Health -
München

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Microsoft Office
Bachelor
Klinische Studien

Vollständige Stellenbeschreibung

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

The Study Start Up (SSU) Associate function is to support the SSU Manager with all SSU-related activities in collaboration with other clinical research stakeholders and to serve as a contact for local/global SSU process improvements.

Job Description

THE STUDY START UP ASSOCIATE ROLE

KEY RESPONSABILITIES

Coordinates and assists with all start up activities prior to site activation, including but not limited to:

Submission of required documents to ethic committees, regulatory authorities, sites and sponsor.
Submission of the clinical study agreement for review, as needed.
Contribution to/coordination of site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements.
Contribution to localize global Informed Consent Form (ICF) with country requirements.
Understanding and dissemination of information related to Ethics Committee, meeting dates & costs to relevant stakeholders.
Understanding and dissemination of information related to Ethics applications & associated online systems.
Clinical Trial Health Authority application and regulatory submission process.
Supporting with the Contracts & Indemnity request process.
Collation/provision of other materials and documentation used by the study requiring local governance approval.
Maintain up to date knowledge, ensuring study adherence and compliance with local regulatory requirements and associated documentation in line with SSU Manager oversight/input.
Contribute to collation of metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contract negotiation.
Ensure all start up information & requirements are kept up to date in a central repository for project teams.
Track metrics and study start-up timelines to identify trends and opportunities for improvement.
Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities.
Assist with identification and tracking of new sites in collaboration with CRAs.

DESIRED QUALIFICATION & EXPERIENCE

University Degree or equivalent preferably in a medical/science-related field.
Prior work experience demonstrating knowledge and understanding of clinical trials.
Demonstrated knowledge and understanding of ICH-GCP and a desire to increase specialist knowledge in regulatory, ethics and contractual requirements for SSU in clinical trials for European and international trials.

TECHNICAL COMPETENCES & SOFT SKILLS

Good communications skills including the ability to: ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.
Experience in working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork.
Self-motivated, assertive, and displays initiative.
Proven organizational skills and the ability to prioritize and manage multiple tasks with flexibility.
Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
Availability to travel domestically and internationally if required.

WORKING CONDITIONS/PHYSICAL DEMANDS

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.

Languages

English

Education

Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Medicine

Contract Type

Regular

Jetzt bewerben

Erweiterte Suche

documentation specialist Jobs in münchen

Study Start Up Associate

Executive Project Management and Reporting Specialist (m/f/d) at Allianz SE

Junior Quality Control Specialist - Incoming Inspection (all genders)

TECHNICAL SPECIALIST (M/F/D) – RADIO REMOTE CONTROL SYSTEMS

IT Support Specialist (m/f/d)

Customer Support Specialist (all genders)

Quality Control Specialist (all genders)

Pension & Benefits Specialist (m/w/d)

ESG Data Management Specialist (m/f/d) - (limited 12-15 months)

Support Specialist (MACE Audit) (f/m/d)

Customer Support Specialist (all genders)

Support Specialist (MACE Audit) (f/m/d)

Technical Documentation Specialist – Railway Display and Audio Systems & Device Engineering (m/w/d)

Specialist, Programme Schedule Management, IRIS2

Building Maintenance Specialist

Platform Integration - Senior Trading Technology Specialist (m/f/d)*

Quality Specialist - Travel Claims

Procurement & Supply Chain Specialist for Drones & Embedded Electronics

IT Support Specialist

Senior Regulatory Affairs Specialist (m/w/d)

Ich möchte aktuelle Job-E-Mails für Stellen als documentation specialist in münchen erhalten

Related Searches

Weitere Job-Standorte erkunden

THE STUDY START UP ASSOCIATE ROLE

KEY RESPONSABILITIES

DESIRED QUALIFICATION & EXPERIENCE

TECHNICAL COMPETENCES & SOFT SKILLS

Tools für Jobsuchende

Arbeitgebertools

Durchsuchen

Bleiben Sie in Kontakt