PSI CRO
Senior / Clinical Research Associate(m/w/x)
Full-timeWith HomeofficeSenior
München
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PPPPD Germany GmbH & Co KG
CRA II / Sr CRA - FSP Vaccines(m/w/x)
München
Full-timeRemoteJunior
Nejo AI Summary
Remote and on-site monitoring of vaccine clinical trials for a global FSP provider. Experience in Oncology and Vaccine studies preferred. Regular travel for on-site monitoring visits.
Requirements
- Degree in life sciences, Nursing certification, or equivalent
- Experience comparable to 1 year clinical monitoring
- Valid driver's license
- Equivalent combination of education and experience
- Experience in Oncology and Vaccine studies
- Proven clinical monitoring skills
- Medical terminology and therapeutic area knowledge
- Knowledge of ICH GCPs and regulations
- Critical thinking and problem solving skills
- Ability to manage Risk Based Monitoring
- Good oral and written communication skills
- Customer focus and listening skills
- Organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Flexibility and adaptability
- Ability to work independently or in teams
- Good computer skills and Microsoft Office
- Fluency in English and German
- Good presentation skills
- Willingness for frequent travel and driving
Tasks
- Conduct remote and on-site monitoring visits
- Assess protocol and regulatory compliance
- Manage clinical monitoring and site management
- Follow sponsor-specific procedures and guidelines
- Ensure adherence to ICH-GCP and SOPs
- Guarantee subject well-being and data reliability
- Maintain audit readiness at all times
- Develop collaborative relationships with investigational sites
- Apply risk-based monitoring and root cause analysis
- Identify site process failures and corrective actions
- Verify data accuracy through SDR and SDV
- Perform physical inventory of investigational products
- Document observations in reports and letters
- Escalate and resolve observed deficiencies
- Maintain regular contact with investigative sites
- Execute tasks per the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with team members on finding resolutions
- Attend and participate in investigator meetings
- Identify and qualify potential investigative sites
- Initiate clinical trial sites per regulations
- Perform trial close-out and material retrieval
- Ensure essential documents are complete
- Conduct on-site file reviews
- Provide trial status updates to management
- Update clinical trial management systems
- Facilitate communication between sites and clients
- Respond to regulatory audits and inspections
- Complete expense reports and timesheets
- Assist with project publications and tools
- Contribute to process improvement initiatives
Work Experience
- 1 year
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PPD Germany GmbH & Co KG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Full-time/Part-timeWith HomeofficeSeniorTübingen, München
PPPPD Germany GmbH & Co KG
CRA II / Sr CRA - FSP Vaccines(m/w/x)
München
Full-timeRemoteJunior
Nejo AI Summary
Remote and on-site monitoring of vaccine clinical trials for a global FSP provider. Experience in Oncology and Vaccine studies preferred. Regular travel for on-site monitoring visits.
Requirements
- Degree in life sciences, Nursing certification, or equivalent
- Experience comparable to 1 year clinical monitoring
- Valid driver's license
- Equivalent combination of education and experience
- Experience in Oncology and Vaccine studies
- Proven clinical monitoring skills
- Medical terminology and therapeutic area knowledge
- Knowledge of ICH GCPs and regulations
- Critical thinking and problem solving skills
- Ability to manage Risk Based Monitoring
- Good oral and written communication skills
- Customer focus and listening skills
- Organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Flexibility and adaptability
- Ability to work independently or in teams
- Good computer skills and Microsoft Office
- Fluency in English and German
- Good presentation skills
- Willingness for frequent travel and driving
Tasks
- Conduct remote and on-site monitoring visits
- Assess protocol and regulatory compliance
- Manage clinical monitoring and site management
- Follow sponsor-specific procedures and guidelines
- Ensure adherence to ICH-GCP and SOPs
- Guarantee subject well-being and data reliability
- Maintain audit readiness at all times
- Develop collaborative relationships with investigational sites
- Apply risk-based monitoring and root cause analysis
- Identify site process failures and corrective actions
- Verify data accuracy through SDR and SDV
- Perform physical inventory of investigational products
- Document observations in reports and letters
- Escalate and resolve observed deficiencies
- Maintain regular contact with investigative sites
- Execute tasks per the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with team members on finding resolutions
- Attend and participate in investigator meetings
- Identify and qualify potential investigative sites
- Initiate clinical trial sites per regulations
- Perform trial close-out and material retrieval
- Ensure essential documents are complete
- Conduct on-site file reviews
- Provide trial status updates to management
- Update clinical trial management systems
- Facilitate communication between sites and clients
- Respond to regulatory audits and inspections
- Complete expense reports and timesheets
- Assist with project publications and tools
- Contribute to process improvement initiatives
Work Experience
- 1 year
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PPD Germany GmbH & Co KG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
PPD Germany GmbH & Co KG
Industry
Pharmaceuticals
Description
PPD's Functional Service Provider division partners with and serves as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality.
Not a perfect match?
- PSI CRO
Senior / Clinical Research Associate(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - IQVIA Biotech
Clinical Research Associate 2(m/w/x)
Full-timeRemoteExperiencedFrankfurt am Main, München, Hamburg - Immatics Biotechnologies GmbH
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Full-time/Part-timeWith HomeofficeExperiencedTübingen, München, Berlin - Immatics Biotechnologies GmbH
GCP/ GCLP Auditor as Senior Manager Clinical Quality Assurance(m/w/x)
Full-time/Part-timeWith HomeofficeSeniorTübingen, München