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Clinical Trial Manager Job
Eingestellt von Yoh
Gesuchte Skills: Client, Support
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.
- Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.
- Prepare training materials and presentations related to the planning and conduct of the trial.
- Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
- Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and client local medical organizations.
- Accountable for accuracy of trial information in all trial databases and tracking systems.
- Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD.
- Participate in the organization and logistics of various oversight and Advisory boards; attend meetings.
- Point of contact for managing/answering questions related to trial procedures and patients' eligibility.
- Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. May participate in International Clinical Team meetings.
- Contribute to program level activities (eg, tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
- Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.
- Contribute to talent and career development of OGD staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for OGD training programs.
WHAT YOU NEED TO BRING TO THE TABLE:
- Advanced degree or equivalent education/degree in life science/healthcare required accompanied with two (2) years experience in clinical research
- Understanding of the overall drug development process.
- Knowledge of principles for trial budgeting.
- Basic knowledge of oncology and/or hematology preferable
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Krista Leach
Yoh, a DayJ2W: SCIENTIFIC; MONJOB
TAX TERM: CON_W2J2WMIDATL
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:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges