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Local Study Operations Manager(m/w/x)
Managing clinical trials from start-up to close-out for a global clinical research provider. Advanced German (C1) and local regulatory expertise required. Study start-up process and timelines knowledge essential.
Requirements
- Bachelor’s degree and 5 years of directly related experience
- Advanced knowledge of global clinical trial management
- Local knowledge/expertise of regulatory environment
- Expertise of study start up process and timelines
- Advanced German level (min. C1)
- 2 years’ experience of leading local/regional teams
- Proven work experience in clinical trial project management
- Relevant Therapeutic knowledge (Obesity) preferred
- Experience in oversight of external vendors
- Ability to work effectively in team/matrix environment
- Ability to work on multiple projects
- Proven ability to work independently
- Effective handling of multiple priorities
- Experience in fast-paced environment
- Risk management skills
- Strong organizational skills
- Strong self-management skills
- Strong planning skills
Tasks
- Lead and manage clinical trials from start-up to close-out
- Collaborate with cross-functional internal and external stakeholders
- Ensure timely execution and budget adherence of clinical trial deliverables
- Provide high-level country strategy and drive study progress
- Plan and oversee clinical study execution according to global program strategy
- Support country-level operational planning and site selection
- Develop and contribute to program/study-specific materials
- Communicate country status, timelines, and deliverables to stakeholders
- Set and manage site-level goals and study-specific deliverables
- Train CRA, Investigators, and Study Coordinators
- Monitor and oversee vendor activities
- Engage with local cluster team and functions from a study perspective
- Provide input into the Country Operational Plan
- Partner with DFM for feasibility and GCMs for local delivery
- Approve Baseline and Revised Enrolment Plans
- Contribute to study-level forecast for investigational product
- Support study-level accountability and reconciliation
- Manage the ELE process
- Monitor clinical study execution against timelines, deliverables, and budget
- Translate global start-up requirements into local targets
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
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Local Study Operations Manager(m/w/x)
Managing clinical trials from start-up to close-out for a global clinical research provider. Advanced German (C1) and local regulatory expertise required. Study start-up process and timelines knowledge essential.
Requirements
- Bachelor’s degree and 5 years of directly related experience
- Advanced knowledge of global clinical trial management
- Local knowledge/expertise of regulatory environment
- Expertise of study start up process and timelines
- Advanced German level (min. C1)
- 2 years’ experience of leading local/regional teams
- Proven work experience in clinical trial project management
- Relevant Therapeutic knowledge (Obesity) preferred
- Experience in oversight of external vendors
- Ability to work effectively in team/matrix environment
- Ability to work on multiple projects
- Proven ability to work independently
- Effective handling of multiple priorities
- Experience in fast-paced environment
- Risk management skills
- Strong organizational skills
- Strong self-management skills
- Strong planning skills
Tasks
- Lead and manage clinical trials from start-up to close-out
- Collaborate with cross-functional internal and external stakeholders
- Ensure timely execution and budget adherence of clinical trial deliverables
- Provide high-level country strategy and drive study progress
- Plan and oversee clinical study execution according to global program strategy
- Support country-level operational planning and site selection
- Develop and contribute to program/study-specific materials
- Communicate country status, timelines, and deliverables to stakeholders
- Set and manage site-level goals and study-specific deliverables
- Train CRA, Investigators, and Study Coordinators
- Monitor and oversee vendor activities
- Engage with local cluster team and functions from a study perspective
- Provide input into the Country Operational Plan
- Partner with DFM for feasibility and GCMs for local delivery
- Approve Baseline and Revised Enrolment Plans
- Contribute to study-level forecast for investigational product
- Support study-level accountability and reconciliation
- Manage the ELE process
- Monitor clinical study execution against timelines, deliverables, and budget
- Translate global start-up requirements into local targets
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
IQVIA RDS GmbH
Industry
Healthcare
Description
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
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