20 beste Stellen als clinical development leader in berlin, be – aktuell auf Personalsuche

Clinical Research Coordinator
Parexel —Berlin
- Wochenendarbeit möglich
- Windows
- PC-Kenntnisse
Regional Medical Advisor m/w/d HKL/Kardiologie
IQVIA —Berlin
- Vollzeit
- Medizin
- Doktorat
- Englisch
Position: Clinical Operations Manager
Meditrial Europe Ltd. —Berlin
- Vollzeit
- Englisch
- Forschungserfahrung
- Master
Research Product Team Lead m/f/d
Bayer —Berlin
- 129.700 € – 163.800 € pro Jahr
- Teilzeit
- Doktorat
- Englisch
- Forschungserfahrung
20 Std.
MSL Germany
Curium Pharma —Berlin
- Master
Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based
IQVIA —Berlin
- Vollzeit
- Doktorat
- Schreibfähigkeiten
- Forschungserfahrung
Regulatory Affairs Manager - Pharma/Medical Device
Meditrial Europe Ltd. —Berlin
- Vollzeit
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Senior HCP Engagement Manager (f/m/d)
Sonova —Berlin
- Hybrides Arbeiten
- Bachelor
- Mit Reiseanteil
- Wirtschaft
Community Outreach & Engagement Manager – all genders
Sanofi —Berlin
- 83.856 € – 125.784 € pro Jahr
- Master
- Projektmanagement
- Mit Reiseanteil
- Flexible Arbeitszeiten
Medical Science Liaison Oncology
BioNTech AG —Berlin
- Vollzeit
- Doktorat
- Projektmanagement
- Flexible Arbeitszeiten
Key Account Manager (KAM) - Germany
Corcept Therapeutics —Berlin
- Vertrieb
- Bachelor
- Mit Reiseanteil
Product Designer (UX/UI) (m/f/x)
Progyny Global —Berlin
- 60.000 € – 70.000 € pro Jahr
- Hybrides Arbeiten
- Forschungserfahrung
- Homeoffice-Möglichkeit
Direkt bewerben
7 Tage
Global Sales Enablement Manager (d/f/m)
Ottobock SE & Co. KGaA —Berlin
- Vollzeit
- Vertrieb
- Bachelor
- Produktmanagement
- Flexible Arbeitszeiten
6 Tage
Key Account Manager Trade Business (m/w/d) Region Nord- und Ostdeutschland
Coloplast —Berlin
- Vollzeit
- Englisch
- Microsoft Office
- Analysefähigkeit
- Weiterbildungsprogramme
- Empfehlungsprogramm
Director, Integrated Product Medical Lead (m/f/d)
Bayer —Berlin
- Teilzeit
- Doktorat
- Englisch
- Patientenbehandlung
Enterprise Account Executive (w/m/d)
Flinn.ai —Berlin
- Vollzeit
- Hybrides Arbeiten
- CRM-Software
- Vertrieb
- Bachelor
- Flexible Arbeitszeiten
Director, Business Development - CE
RxLogix Corporation —Berlin
- Vollzeit
- Homeoffice
- Vertrieb
- Kundenberatung
- Mit Reiseanteil
Direkt bewerben
Head of Sales Europe & APAC Medical Universities
AMBOSS —Berlin
- Vollzeit
- Hybrides Arbeiten
- CRM-Software
- Vertrieb
- Unternehmensentwicklung
Principal/Sr Principal - Global Custom Integrated Research
IQVIA —Berlin
- Vollzeit
- Forschungserfahrung
Product Owner Software eHealth (m/w/div)
Semdatex —Berlin
- Vollzeit
- Informatik
Direkt bewerben
15 Std.

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clinical development leader jobs near berlin, be

Clinical Research Coordinator

Parexel -
Berlin

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Details zur Stelle

Qualifikationen

Windows
PC-Kenntnisse

Vollständige Stellenbeschreibung

The Clinical Research Coordinator is accountable for the planning, preparation, and execution of clinical trials in conjunction with the Team Leader, Project Manager, and Investigator. This role ensures that clinical studies are conducted according to the study protocol, ICH GCP guidelines, and unit SOPs. The coordinator assists in the conduct of Phase I-III studies across all therapeutic areas, ensuring studies are prepared to the highest standard within specified timelines. The role also involves clinical conduct oversight, data cleaning, and deviations management.

Key Accountabilities:

Technical supervision of Clinical Research Nurse, assigned to the studies
Control and direct activities and staff during key operational aspects of assigned studies
Organization and Preparation of clinical studies, as listed below:
- Study Protocol review and study feasibility prove
- Review of all other study related documents e.g., CRF, Lab Manual, Reference Manual
- Review Protocol Deviation Assessment Plan (PDAP) and Data Verification Specification (DVS). Be involved in project development, taking part in early internal project discussions.
- Early recognition of areas of potential problems, provide contingency plans or address the issue in an appropriate way with the required departments and give input into possible solutions (RACT).
- Escalate issues as soon as possible. Open QI in timely manner, close actions on or before the end date.
- Record Clinical including medical deviations on the Observable protocol deviations (PD) log.
- Review combined PD log.
- Generation of general working instructions, source data sheets and other relevant forms and documents for the allocated clinical studies
- Generation and maintenance of the general and emergency case files, Staff Log, Window Allowance Agreement, Source Data Verification
- Training / Training organization of personnel assigned to the study
- Organization of study specific training
- Organization of the generation of dietary plans/meal plans
- Verification and maintenance of the file containing the volunteers informed consent forms
- Organization of study specific material and medical devices
- Lead ClinBase setup development across pharmaceutical services, laboratory, database design, and clinical operations for all assigned studies
- Monitor that ClinBase set up activities and ensure that it is developed within the given time.
- Prepare ClinBase set-up requirements forms for Screening and Experimental.
- If EDC is in use review annotated CRF and perform UAT.
- Review the ClinBase set up procure list, time windows, normal ranges as part of pre-dummy review.
- Check User Defined Procedures on Feasibility
- Approve the set up for Clinical use to ensure study requirements are captured as per protocol and in accordance with sponsor requirements (WAA, Normal Ranges, Lab Profile, order of procedures, relative time User Defined Procedures)
- Initiate ClinBase revisions and subsequent approval.
- Care support of the volunteers participating in a study from admission to discharge
- Coordination of study-preparations on the ward incl. providing medical technique, sample container, documentation computers, bed
- Providing study relevant shift to shift information
- Ensuring all study related assessments and medical measurements will be performed according to study protocol and relevant clinical guidelines (GCP and ICH guidelines)
- Ensuring all study relevant documentations are going to performed according to study protocol and ICH/GCP guidelines
- Overseeing, maintaining, and leading the processes and progresses of all allocated studies in conjunction with study physician, project management and data management
- Volunteer payment management
- Management/Organization of medication storage, drug check in and out
- Issuing of Audit Reports on internal and external quality audit findings
- Resolution of data clarification queries
- Management of CRF Shipment, Source Data storing and archiving after study finalization

Cooperation with the study monitor, incl. preparation for monitor visits, cleaning and correcting of study relevant documents according to monitor/protocol demands
Perform investigations on subjects (physiological measurements including ECG, Blood Pressure, Lung Function, venous puncture and other) according to the study protocol
Use of psychological and physiologic test procedures
Cooperation with other internal departments as a company’s study team member
Participation in project team meetings
Study presentation in internal study initiation meetings
Participation in client meetings
Administration of Investigational Products
Other tasks in the opinion of the manager and need of the CPRU.

Skills:

Fluent knowledge of German and Intermediate English skills (written and spoken)
Computer skills (Windows Office)
Organizational talent
Ability to work under pressure and flexibility in working times (early, late and night shifts)
Ability to work on weekends and holidays
Knowledge of ICH-GCP Guidelines.

Knowledge and Experience:

Relevant experience in hospitals or medical surgery.

Education:

Terminated education as nurse, MTA, doctor´s assistant, paramedic, or similar/equivalent qualification/education.

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Erweiterte Suche

clinical development leader Jobs in berlin, be

Clinical Research Coordinator

Regional Medical Advisor m/w/d HKL/Kardiologie

Position: Clinical Operations Manager

Research Product Team Lead m/f/d

MSL Germany

Global Scientific Lead - Clinical Outcome Assessment (COA) Strategy Consulting - Multiple locations - Hybrid/Home-based

Regulatory Affairs Manager - Pharma/Medical Device

Senior HCP Engagement Manager (f/m/d)

Community Outreach & Engagement Manager – all genders

Medical Science Liaison Oncology

Key Account Manager (KAM) - Germany

Product Designer (UX/UI) (m/f/x)

Global Sales Enablement Manager (d/f/m)

Key Account Manager Trade Business (m/w/d) Region Nord- und Ostdeutschland

Director, Integrated Product Medical Lead (m/f/d)

Enterprise Account Executive (w/m/d)

Director, Business Development - CE

Head of Sales Europe & APAC Medical Universities

Principal/Sr Principal - Global Custom Integrated Research

Product Owner Software eHealth (m/w/div)

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