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Associate Medical Director- Oncology ,Sponsor-Dedicated(m/w/x)
Managing medical content for oncology clinical trial protocols for life sciences clients. 5-7 years' clinical medicine experience and a medical degree required. Sponsor-dedicated role within clinical research services.
Anforderungen
- Medical degree from accredited, internationally recognized medical school
- Minimum 5-7 years' experience in clinical medicine
- Robust, current knowledge of scientific, clinical, regulatory, commercial, competitive landscape
- Knowledge of federal, local regulations, guidelines for clinical research
Aufgaben
- Serve as a core member of trial teams.
- Manage medical content in Clinical Trial Protocols.
- Collaborate with project, safety, writing, and trial teams.
- Provide medical input for CTP updates.
- Define medically critical data, processes, and risks.
- Contribute to the Integrated Quality and Risk Management Plan.
- Participate in risk discussions during trial conduct.
- Co-author the Clinical Quality Monitoring Plan.
- Align CQMP with IQRMP risks and mitigations.
- Provide medical input on important protocol deviations.
- Review and support decisions on iPDs.
- Address and communicate clinical quality issues.
- Contribute to preparing core trial documents and milestones.
- Design eCRFs and translate medical questions.
- Develop Information for CRF Completion (ICC).
- Develop Data Review Plans.
- Specify lab parameters.
- Contribute to Data Transfer Agreements and alerts.
- Manage medical content for patient information.
- Manage medical content for informed consent.
- Manage medical content for trial monitoring manuals.
- Manage medical content for communication and training plans.
- Manage medical content for statistical analysis plans.
- Contribute to patient narrative preparation.
- Plan and review medical sections of Clinical Trial Reports.
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
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Associate Medical Director- Oncology ,Sponsor-Dedicated(m/w/x)
Managing medical content for oncology clinical trial protocols for life sciences clients. 5-7 years' clinical medicine experience and a medical degree required. Sponsor-dedicated role within clinical research services.
Anforderungen
- Medical degree from accredited, internationally recognized medical school
- Minimum 5-7 years' experience in clinical medicine
- Robust, current knowledge of scientific, clinical, regulatory, commercial, competitive landscape
- Knowledge of federal, local regulations, guidelines for clinical research
Aufgaben
- Serve as a core member of trial teams.
- Manage medical content in Clinical Trial Protocols.
- Collaborate with project, safety, writing, and trial teams.
- Provide medical input for CTP updates.
- Define medically critical data, processes, and risks.
- Contribute to the Integrated Quality and Risk Management Plan.
- Participate in risk discussions during trial conduct.
- Co-author the Clinical Quality Monitoring Plan.
- Align CQMP with IQRMP risks and mitigations.
- Provide medical input on important protocol deviations.
- Review and support decisions on iPDs.
- Address and communicate clinical quality issues.
- Contribute to preparing core trial documents and milestones.
- Design eCRFs and translate medical questions.
- Develop Information for CRF Completion (ICC).
- Develop Data Review Plans.
- Specify lab parameters.
- Contribute to Data Transfer Agreements and alerts.
- Manage medical content for patient information.
- Manage medical content for informed consent.
- Manage medical content for trial monitoring manuals.
- Manage medical content for communication and training plans.
- Manage medical content for statistical analysis plans.
- Contribute to patient narrative preparation.
- Plan and review medical sections of Clinical Trial Reports.
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
IQVIA
Branche
Healthcare
Beschreibung
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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