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Clinical Trial Leader Job
Eingestellt von Yoh
Gesuchte Skills: Design, Client
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:
- Good GCP knowledge
- Basic understanding of oncology and/or hematology
- Early Clinical Development experience
- Publishing Clinical Studies
WHAT YOU'LL BE DOING:
- Accountable for all aspects of assigned OTM clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials.
- Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.
- Contribute to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
- In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
- Prepare and run dose escalation meetings with investigators.
- Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget
- Accountable for accuracy of trial information in all trial databases and tracking systems.
- Sits on Early Program Team (EPT) to contribute to program strategy.
- Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties
- Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned.
WHAT YOU NEED TO BRING TO THE TABLE:
- Four (4) or more years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
- Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
- Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred.
- Hands-on experience in data cleaning and analysis recommended.
- Fluent in English
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Kara Lloyd
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: CLINICAL
MONJOBJ2WNECLIN
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
East Hanover, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design