11 beste Stellen als study start up clinical in home office – aktuell auf Personalsuche

Clinical Research Associate
BeiGene —Home Office
- 55.100 € – 68.900 € pro Jahr
- Vollzeit
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- Organisationstalent
Clinical Study Manager Neurovascular (m/f/d)
Penumbra —Home Office
- Homeoffice
- Bachelor
- Mit Reiseanteil
- Kommunikationsfähigkeit
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Clinical Research Manager
BeiGene —Home Office
- 83.400 € – 104.300 € pro Jahr
- Vollzeit
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- Bachelor
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Project Manager II, Early Phase (Germany)
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Manager Clinical Programs Neurovascular (m/f/d)
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Sr. Clinical Research Associate (Germany)
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Country Approval Specialist - FSP - Germany (m/f/d)
Thermo Fisher Scientific —Home Office
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Country Operations Lead - FSP, Germany (m/w/d)
Thermo Fisher Scientific —Home Office
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Site Monitoring Lead (SML) sponsor dedicated in Germany
Syneos - Clinical and Corporate - Prod —Home Office
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サイネオス・ヘルス —Home Office
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Indero —Home Office
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Direkt bewerben

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Clinical Research Associate

BeiGene -
Home Office

Jetzt bewerben

Details zur Stelle

Vollzeit
55.100 € – 68.900 € pro Jahr

Qualifikationen

Organisationstalent

Vollständige Stellenbeschreibung

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
Identify gaps and areas for improvement and propose CAPA.
Supports start-up and provides local expertise.
SSU experience is considered a plus

CRA activities

Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets
Provides protocol and related study training to assigned sites.
Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs
Conducts co-monitoring visits, if required
Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP
Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
Ensure inspection readiness of the study and sites
Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
Attends disease indication project specific training and general CRA training as required
Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.

Education Required:

BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.
Experience in oncology global trials preferred

Other Qualifications:

Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
Experience in oncology/hematology trials preferred
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
Fluent in English & German (writing and speaking)

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Travel: up to 60%

Salary Range EU: 55,100.00 EUR - 68,900.00 EUR

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Jetzt bewerben

Erweiterte Suche

study start up clinical Jobs in home office

Clinical Research Associate

Clinical Study Manager Neurovascular (m/f/d)

Clinical Research Manager

Project Manager II, Early Phase (Germany)

Manager Clinical Programs Neurovascular (m/f/d)

Sr. Clinical Research Associate (Germany)

Country Approval Specialist - FSP - Germany (m/f/d)

Country Operations Lead - FSP, Germany (m/w/d)

Site Monitoring Lead (SML) sponsor dedicated in Germany

Site Monitoring Lead (SML) sponsor dedicated in Germany

Project Director, Dermatology & Rheumatology CRO, Germany

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