IQVIA
Local Study Associate Director - Sponsor Dedicated(m/w/x)
Full-timeOn-siteExperienced
Frankfurt am Main
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IQIQVIA
Associate Clinical Project Manager(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Managing patient-focused clinical studies for life sciences clients. 2 years clinical research experience required. 4-day work week, company car for private use.
Requirements
- Bachelor's degree in life sciences or related field
- 2 years clinical research experience
- Intermediate knowledge of job area principles, theories, concepts
- Knowledge of clinical trial conduct
- Skill in applying ICH GCP and local regulations
- Broad protocol knowledge desired
- Therapeutic knowledge desired
- Strong written and verbal communication skills
- Very good command of English language
- Strong problem-solving skills
- Ability to organize resources for tasks
- Ability to set objectives and provide clear direction
- Experience planning activities in advance
- Account for possible changing circumstances
- Ability to handle conflicting priorities
- Results-oriented approach to work
- Ability to establish and maintain effective working relationships
- Ability to work across geographies
- High awareness and understanding of cultural differences
- Good understanding of project financials
Tasks
- Liaise with clinical teams to improve patient lives
- Deliver clinical studies to meet contractual requirements
- Ensure adherence to SOPs, policies, and practices
- Support efforts to drive operational excellence
- Support efforts to drive strategic leadership with customers
- Run own studies as part of development
- Work with IQVIA Clinical Operations team and other members
- Ensure exhaustive feasibility reports
- Review site feasibility reports
- Support CTM in site selection
- Verify timely collection of essential documents
- Ensure all set-up activities are completed before site initiation
- Ensure clinical responsibility tasks in EDC system are completed on time
- Support Clinical Operations in training CRAs
- Participate in organizing monitor and investigator meetings
- Assist CTM/study team in evaluating timelines
- Assist CTM/study team in establishing milestones
- Assist in producing documents for clinical activity implementation
- Assist in producing documents for monitoring
- Assist in producing documents for reporting
- Validate final clinical study documents
- Review site visit reports
- Ensure timely follow-up of issues raised by monitors
- Provide support and guidance to Internal CTAs
- Set up regular meetings with MSL to support Clinical Operations
- Participate in ongoing clinical study data reviews
- Ensure timelines for data collection are met
- Ensure timelines for data clarifications/queries are met
- Ensure study samples/assessments flow per protocol between stakeholders
- Participate in TMF quality check reviews
- Ensure TMF completion during study
- Ensure TMF final review before archiving
- Prepare study systems (IWRS/IMP forecasting/flow)
- Follow up on study systems (IWRS/IMP forecasting/flow)
- Prepare study documents
- Perform site visits before audits/inspections
- Assist in audit follow-up
- Assist in findings resolution
- Complete co-monitoring visits
- Perform study-related functions to ensure execution aligns with GCP
- Perform study-related functions to ensure execution aligns with other standards
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ICH GCP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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.
Not a perfect match?
- Fresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - IQVIA
Associate Medical Director- Oncology ,Sponsor-Dedicated(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main - GBG Forschungs GmbH
Teamleiter:in Clinical Project Management Assistance(m/w/x)
Full-timeOn-siteExperiencedNeu-Isenburg - IQVIA RDS GmbH
Clinical Trial Educator I(m/w/x)
Full-timeOn-siteJuniorFrankfurt am Main
IQIQVIA
Associate Clinical Project Manager(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Managing patient-focused clinical studies for life sciences clients. 2 years clinical research experience required. 4-day work week, company car for private use.
Requirements
- Bachelor's degree in life sciences or related field
- 2 years clinical research experience
- Intermediate knowledge of job area principles, theories, concepts
- Knowledge of clinical trial conduct
- Skill in applying ICH GCP and local regulations
- Broad protocol knowledge desired
- Therapeutic knowledge desired
- Strong written and verbal communication skills
- Very good command of English language
- Strong problem-solving skills
- Ability to organize resources for tasks
- Ability to set objectives and provide clear direction
- Experience planning activities in advance
- Account for possible changing circumstances
- Ability to handle conflicting priorities
- Results-oriented approach to work
- Ability to establish and maintain effective working relationships
- Ability to work across geographies
- High awareness and understanding of cultural differences
- Good understanding of project financials
Tasks
- Liaise with clinical teams to improve patient lives
- Deliver clinical studies to meet contractual requirements
- Ensure adherence to SOPs, policies, and practices
- Support efforts to drive operational excellence
- Support efforts to drive strategic leadership with customers
- Run own studies as part of development
- Work with IQVIA Clinical Operations team and other members
- Ensure exhaustive feasibility reports
- Review site feasibility reports
- Support CTM in site selection
- Verify timely collection of essential documents
- Ensure all set-up activities are completed before site initiation
- Ensure clinical responsibility tasks in EDC system are completed on time
- Support Clinical Operations in training CRAs
- Participate in organizing monitor and investigator meetings
- Assist CTM/study team in evaluating timelines
- Assist CTM/study team in establishing milestones
- Assist in producing documents for clinical activity implementation
- Assist in producing documents for monitoring
- Assist in producing documents for reporting
- Validate final clinical study documents
- Review site visit reports
- Ensure timely follow-up of issues raised by monitors
- Provide support and guidance to Internal CTAs
- Set up regular meetings with MSL to support Clinical Operations
- Participate in ongoing clinical study data reviews
- Ensure timelines for data collection are met
- Ensure timelines for data clarifications/queries are met
- Ensure study samples/assessments flow per protocol between stakeholders
- Participate in TMF quality check reviews
- Ensure TMF completion during study
- Ensure TMF final review before archiving
- Prepare study systems (IWRS/IMP forecasting/flow)
- Follow up on study systems (IWRS/IMP forecasting/flow)
- Prepare study documents
- Perform site visits before audits/inspections
- Assist in audit follow-up
- Assist in findings resolution
- Complete co-monitoring visits
- Perform study-related functions to ensure execution aligns with GCP
- Perform study-related functions to ensure execution aligns with other standards
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ICH GCP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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
IQVIA
Industry
Healthcare
Description
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
Not a perfect match?
- IQVIA
Local Study Associate Director - Sponsor Dedicated(m/w/x)
Full-timeOn-siteExperiencedFrankfurt am Main - Fresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - IQVIA
Associate Medical Director- Oncology ,Sponsor-Dedicated(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main - GBG Forschungs GmbH
Teamleiter:in Clinical Project Management Assistance(m/w/x)
Full-timeOn-siteExperiencedNeu-Isenburg - IQVIA RDS GmbH
Clinical Trial Educator I(m/w/x)
Full-timeOn-siteJuniorFrankfurt am Main