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Global Study Mananger Job
Eingestellt von Yoh
Gesuchte Skills: Opl, Client
Projektbeschreibung
What You'll Be Doing:
- Provides direction and leadership to one or more study teams to ensure delivery of all cross functional activities to meet study plans outlined by the clinical development plan.
- Builds and maintains effective high performing teams with clear roles, responsibilities and accountabilities for members
- Ensures study team receives study specific and therapeutic training.
- Creates and manages study timelines, budget, resource, risk and quality plans
- Establishes and maintains accurate study level timeline and resourcing plans and works with Functional Management to have correct resources in place.
- Drives setting of study team goals and milestones and monitors progress.
- Ensures all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF and SSPM (study-specific procedures manual).
- Finalize study budget based upon raw budget estimate from OPL, input from GSM and in alignment with DBA, LCT/DST and SMT assumptions.
- Accountable for study budgets, with appropriate input from the GSM to ensure efficient expenditure and minimal variance between actual and planned spend.
- Oversees the safety reporting activities and ensures reporting timelines are met.
- Ensure clinical data are reviewed in accordance with study Data Quality plans.
- Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
- Leads the identification and selection of vendors and ensures cross functional input into the scope of work.
What You Need to Bring to the Table:
- Life sciences degree or nursing equivalent.
- Strong leaderships and motivational skills developed through leading successful global multi-functional Matrix study teams through all stages of clinical studies
- Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans.
- Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes.
- Demonstrated consistent achievement of team delivery against commitments and goals.
- Experience of influencing and negotiating at all levels to achieve team delivery.
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Krista Leach
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: CLINICAL
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
South San Francisco, 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