20 beste Stellen als clinical lead in home office – aktuell auf Personalsuche

Clinical Operations Lead (Clinical Trial Manager)
Alimentiv —Home Office
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- Vollzeit
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- Forschungserfahrung
- Microsoft Office
- Organisationstalent
Direkt bewerben
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Thermo Fisher Scientific —Home Office
- Vollzeit
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- Kundenberatung
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- Doktorat
- Kommunikationsfähigkeit
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BeiGene —Home Office
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- Vollzeit
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Senior CRA Germany - metabolic diseases
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- Bachelor
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Customer Success Manager - Clinical Operations
Veeva Systems —Home Office
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- Vollzeit
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- Mit Reiseanteil
- Homeoffice-Möglichkeit
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Director, Clinical Trial Management
Alimentiv —Home Office
- 98.500 € – 164.000 € pro Jahr
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- Organisationstalent
- Führungserfahrung
Direkt bewerben
Head of Medical Advisors Hematology
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- CRM-Software
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Associate Director, Patient Engagement
Asklepios BioPharmaceutical —Home Office
- Vollzeit
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- Bachelor
- Mit Reiseanteil
- Führungserfahrung
Local Clinical Trial Manager - FSP, Germany (m/w/d)
Thermo Fisher Scientific —Home Office
- Vollzeit
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- Englisch
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Sr. TMF Lead
Alimentiv —Home Office
- 59.500 € – 99.500 € pro Jahr
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- Bachelor
Direkt bewerben
Clinical Specialist Central Germany (m/f/d)
Penumbra —Home Office
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- Mit Reiseanteil
- Employee Assistance Program
Senior CRA - Phase I oncology trials - Hamburg/Berlin region
Syneos - Clinical and Corporate - Prod —Home Office
- Vollzeit
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- Bachelor
Therapy Awareness Representative Watchman (f/m/d)
Boston Scientific —Home Office
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Principal Business Consultant - R&D - Clinical
Veeva Systems —Home Office
- 160.000 € – 260.000 € pro Jahr
- Vollzeit
- Homeoffice
- Bachelor
- Führungserfahrung
- Homeoffice-Möglichkeit
Commercial Business Development Manager Discovery, ProBio CDMO
GenScript/ProBio —Home Office
- Homeoffice
- Vertrieb
- Bachelor
Direkt bewerben
Manager, Monitoring & Site Management
Alimentiv —Home Office
- 76.500 € – 127.500 € pro Jahr
- Vollzeit
- Homeoffice
- Organisationstalent
- Führungserfahrung
Direkt bewerben
Project Manager II (Germany)
Indero —Home Office
- Homeoffice
- Forschungserfahrung
- Microsoft Office
- Projektmanagement
- Aufstiegsmöglichkeiten
Direkt bewerben

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Clinical Operations Lead (Clinical Trial Manager)

Alimentiv -
Home Office

Direkt bewerben

Details zur Stelle

Festanstellung | Vollzeit
58.000 € – 96.500 € pro Jahr

Qualifikationen

Forschungserfahrung
Microsoft Office
Organisationstalent
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

Project Oversight

Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
Oversee regional startup and feasibility activities.
Assist in vendor management activities as required per project.
Perform review of visit reports for quality, compliance and appropriate site management.
Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.

Project Liaison

Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
Attend meetings with Study Sponsor to provide status updates on country and site progress
Provide operational support and guidance to the monitoring team throughout project.
Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.
Support line managers by providing status updates on utilization and performance of CRAs.
Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.

Study Documents and Plans

Develop training materials and study tools for sites and CRAs, including monitoring plans.
Develop and implement enrolment and recruitment strategies together with clinical project team.
Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.

Qualifications

College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading

Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training

Other

Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Working Conditions

Home-based

+ Bonus

Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to [email protected]

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Direkt bewerben

Erweiterte Suche

clinical lead Jobs in home office

Clinical Operations Lead (Clinical Trial Manager)

Assistant CRA - FSP (m/f/d)

Therapeutic Area Specialist Süd/West

Scientific Affairs Manager - Germany (North East)

Regional Clinical Study Manager

Associate Director, Healthcare Compliance - Germany

Senior CRA Germany - metabolic diseases

Customer Success Manager - Clinical Operations

Director, Clinical Trial Management

Head of Medical Advisors Hematology

Associate Director, Patient Engagement

Local Clinical Trial Manager - FSP, Germany (m/w/d)

Sr. TMF Lead

Clinical Specialist Central Germany (m/f/d)

Senior CRA - Phase I oncology trials - Hamburg/Berlin region

Therapy Awareness Representative Watchman (f/m/d)

Principal Business Consultant - R&D - Clinical

Commercial Business Development Manager Discovery, ProBio CDMO

Manager, Monitoring & Site Management

Project Manager II (Germany)

Ich möchte aktuelle Job-E-Mails für Stellen als clinical lead in home office erhalten

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