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Senior Clinical Trial Manager Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Pharmaceutical
- Logistics
- Clinical Trials
- Oncology
WHAT YOU'LL BE DOING:
- Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
- Serve as the primary operational contact for the study and lead the cross-functional global team for execution of the study.
- Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams.
- The Clinical Trial Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
- Responsible for the development and management of vendor scope of work (SOW) per contract, quality, and budget.
- Review/approval of vendor invoices and management of accruals and SOW changes.
- Oversight of clinical monitoring quality and adherence to established processes and plans.
WHAT YOU NEED TO BRING TO THE TABLE:
- BA/BS Degree in relevant discipline.
- MINIMUM 6 years clinical study management experience (directly leading cross-functional protocol implementation team) with at least 2 years direct multinational study management experience.
- MINIMUM of 2 years experience in oversight of CRO study execution.
- 3 years recent hematology/oncology experience.
- Requirement of MS Applications including (but not limited to) MS Project, Word, Excel. Study Tools including electronic system skills - CTMS/EDC.
- Strong logistics and study management skills.
- Should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Masters Degree preferred.
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER:Corrin Pyle
Yoh, a DayJ2W: SCIENTIFIC; MONJOB
TAX TERM: CON_W2J2WMIDATL
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Basking Ridge, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung