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Clinical Study Manager Job

Eingestellt von Yoh

Gesuchte Skills: Client

Projektbeschreibung

CLINICAL STUDY MANAGER needed for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Establishes study timelines and budgets
- Clinical operations management

WHAT YOU'LL BE DOING:

- Provides Direction and Leadership to one or more SMTs
- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans
- Manages the Delivery of Study Activities in Order to Meet Study Plans
- Builds effective, high performing SMTs through influence, integration, motivation and optimization of team performance.
- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, eg, Pharma Business
- Functions as Study Management Team Leader.
- Maintains awareness of external clinical research practices to ensure the SMTs are aware of the risks, priorities, value and impact of their work and contributions.
- Provides input into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.
- In accordance with the overall medical plan, establishes and maintains accurate study level plans in designated resourcing and planning system.
- Is accountable for the development and active management of the study patient recruitment strategies in US Medical Affairs.
- Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.
- Is accountable for the selection, training and direct management of external suppliers supporting US Medical Affairs trials.
- Ensures that data is delivered in accordance with established dataflow timelines.
- Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in Investigator Meetings as necessary.
- Monitors progress against SMT goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.
- Oversees the management of the Clinical Operations studies budget.
- Leads the evaluation of standards across one or more SMT(s) with the objective of enhancing quality, productivity and efficiency.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors degree in a medical/science-related field with 5 years proven experience in Clinical Research/Development
- Ensures that data is delivered in accordance with established dataflow timelines.
- Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in Investigator Meetings as necessary.
- Monitors progress against SMT goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.
- Oversees the management of the Clinical Operations studies budget.
- Leads the evaluation of standards across one or more SMT(s) with the objective of enhancing quality, productivity and efficiency.
- Proven clinical development experience on operational aspects of conducting clinical studies including: vendor/CRO management, leading/working as part of a development team, implementing clinical development/medical plans and coordinating study level activities to deliver data for filing or publication purposes
- Demonstrate experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans

GET HIRED, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

TAX TERM: CON_W2J2WSWSCI

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Yoh