PSI CRO
Central Monitoring Manager(m/w/x)
Full-timeWith HomeofficeExperienced
München
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ALAlira Health GmbH
Vice President, Monitoring and Site Engagement(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Overseeing Directors of Clinical Monitoring across Europe and North America for a clinical leadership organization. 15 years of industry experience and 8 years of management experience required. Normal office working conditions, occasional lifting up to 30 lbs.
Requirements
- 15 years pharmaceutical/biotechnology/CRO industry experience
- 8 years management experience
- Monitoring all clinical trial phases
- Previous sponsor/pharmaceutical company experience
- Client oversight/management experience
- Proven leadership skills
- Strong organizational management skills
- Excellent written and verbal communication skills
- Strong interpersonal skills in fast-paced environment
- Strong interpersonal skills in deadline-oriented environment
- Strong interpersonal skills in changing environment
- Excellent multi-tasking ability
- Excellent administrative detail handling
- Ability to handle tasks in fast-paced environment
- Ability to handle tasks in constantly changing environment
- Sound judgment and independent decision-making
- Excellent self-motivation skills
- Thorough understanding of drug development process
- Thorough understanding of regulatory aspects of clinical development
- Thorough understanding of ICH Good Clinical Practices
- Strong interpersonal skills
- Ability to function in a team environment
- Proficient with MS Office Suite
- Proficient with MS Word
- Proficient with MS Excel
- Bachelor of Science (BS)
Tasks
- Oversee Directors of Clinical Monitoring in Europe and North America
- Ensure operational excellence in monitoring activities
- Deliver high-quality outcomes to sponsors
- Meet expectations, timelines, and regulatory standards
- Establish and lead a new organizational unit for feasibility assessments
- Develop and manage a robust network of site partnerships
- Oversee site contracting processes
- Provide strategic and operational leadership to the study start-up group
- Interview, hire, train, and evaluate performance of team members
- Mentor and ensure compliance across assigned teams and activities
- Serve as a leader and point of escalation for Directors of Clinical Monitoring and Study Start-Up
- Develop and maintain a network of clinical study sites
- Facilitate partnerships with institutions for collaboration
- Collaborate with sponsors and Alira Health teams for issue resolution
- Identify and mitigate risks to quality and compliance
- Develop and improve Standard Operating Procedures
- Participate in sponsor and regulatory authority audits
- Monitor clinical team performance indicators and metrics
- Conduct regular resource and workload assessments
- Support professional development and annual reviews of direct reports
- Interview and select potential employees
- Oversee and assess CRAs with the Lead CRA
- Lead corrective action plans for CRAs
- Contribute to proposals and budgets for new projects
- Participate in BID Defense meetings and client presentations
- Assess project budgets, risks, and scope
- Ensure proper project delivery
- Set client expectations for project delivery
- Manage external vendors to ensure contract compliance
- Comply with ICH GCP guidelines, ISO14155, and company SOPs
Work Experience
- 15 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office Suite
- MS Word
- MS Excel
Benefits
Other Benefits
- Normal office working conditions
- Occasional lifting up to 30 lbs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alira Health GmbH 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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ALAlira Health GmbH
Vice President, Monitoring and Site Engagement(m/w/x)
München
Full-timeWith Home OfficeSenior
Nejo AI Summary
Overseeing Directors of Clinical Monitoring across Europe and North America for a clinical leadership organization. 15 years of industry experience and 8 years of management experience required. Normal office working conditions, occasional lifting up to 30 lbs.
Requirements
- 15 years pharmaceutical/biotechnology/CRO industry experience
- 8 years management experience
- Monitoring all clinical trial phases
- Previous sponsor/pharmaceutical company experience
- Client oversight/management experience
- Proven leadership skills
- Strong organizational management skills
- Excellent written and verbal communication skills
- Strong interpersonal skills in fast-paced environment
- Strong interpersonal skills in deadline-oriented environment
- Strong interpersonal skills in changing environment
- Excellent multi-tasking ability
- Excellent administrative detail handling
- Ability to handle tasks in fast-paced environment
- Ability to handle tasks in constantly changing environment
- Sound judgment and independent decision-making
- Excellent self-motivation skills
- Thorough understanding of drug development process
- Thorough understanding of regulatory aspects of clinical development
- Thorough understanding of ICH Good Clinical Practices
- Strong interpersonal skills
- Ability to function in a team environment
- Proficient with MS Office Suite
- Proficient with MS Word
- Proficient with MS Excel
- Bachelor of Science (BS)
Tasks
- Oversee Directors of Clinical Monitoring in Europe and North America
- Ensure operational excellence in monitoring activities
- Deliver high-quality outcomes to sponsors
- Meet expectations, timelines, and regulatory standards
- Establish and lead a new organizational unit for feasibility assessments
- Develop and manage a robust network of site partnerships
- Oversee site contracting processes
- Provide strategic and operational leadership to the study start-up group
- Interview, hire, train, and evaluate performance of team members
- Mentor and ensure compliance across assigned teams and activities
- Serve as a leader and point of escalation for Directors of Clinical Monitoring and Study Start-Up
- Develop and maintain a network of clinical study sites
- Facilitate partnerships with institutions for collaboration
- Collaborate with sponsors and Alira Health teams for issue resolution
- Identify and mitigate risks to quality and compliance
- Develop and improve Standard Operating Procedures
- Participate in sponsor and regulatory authority audits
- Monitor clinical team performance indicators and metrics
- Conduct regular resource and workload assessments
- Support professional development and annual reviews of direct reports
- Interview and select potential employees
- Oversee and assess CRAs with the Lead CRA
- Lead corrective action plans for CRAs
- Contribute to proposals and budgets for new projects
- Participate in BID Defense meetings and client presentations
- Assess project budgets, risks, and scope
- Ensure proper project delivery
- Set client expectations for project delivery
- Manage external vendors to ensure contract compliance
- Comply with ICH GCP guidelines, ISO14155, and company SOPs
Work Experience
- 15 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office Suite
- MS Word
- MS Excel
Benefits
Other Benefits
- Normal office working conditions
- Occasional lifting up to 30 lbs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alira Health GmbH 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Alira Health GmbH
Industry
Healthcare
Description
Alira Health is a clinical leadership organization focused on operational excellence in monitoring, site engagement, and study start-up.
Not a perfect match?
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