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Clinical Data Management (CDM) III Job
Eingestellt von Yoh
Gesuchte Skills: Support, Adobe
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Lead CDM activities for assigned project team.
- Support electronic submission activities.
- Promote and be an advocate of CDM internally and externally
WHAT YOU'LL BE DOING:
- Project manage Clinical Data Management (CDM) activities for all studies within a product/therapeutic indication from Protocol review, Study Start-up to Database Lock and submission/filing.
- Oversee a lead data manager working on studies within a drug area to successfully meet all deliverables, on time, and to a high standard of quality.
- Ensure that Clinical Data Management (CDM) procedures and processes are adhered to and meet business requirements.
- Accountability for meeting study/project timelines.
- Communication within their assigned product teams globally and cross-functionally.
- Review of all study related documents within a project area, ensuring consistency and accuracy of content.
- CDM representation on assigned project teams eg Global Clinical Study Team.
- Support electronic submission activities.
- Critical to have hyper linking and submission management experience, including experience with publishing software (ie Adobe Professional) and Inspection Readiness activities in support of filing activities.
WHAT YOU NEED TO BRING TO THE TABLE:
- General leadership and management experience
- Study Start Up and Filing/Submission experience is a must
- Related experience in CDM
- Experience working in an FSP model
- Use/oversight of EDC systems (RAVE, InForm).
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Salima Hakim
Yoh, a DayJ2W: CLINICAL
MONJOB J2WSWSCI
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Thousand Oaks, 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:
Medien/Design, Sonstiges