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Study Start Up Leader

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2012.02.10.
Jelentkezési határidő: 2012.04.13.
Hirdetés azonosító: 372565


Study Start Up Leader
Our international CRO Client is looking for an experienced clinical research professional to join their team in the following role:
Study Start Up Leader
The Study Start-Up Leader (SSU Leader) is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor during the start-up phase of a project to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met. The SSU Leader may have overall accountability for the execution of the study start-up strategy on the project when a Clinical Operations Leader is not resourced. In case of stand-alone projects, may act as Project Leader for projects involving a small/medium number of countries, where no Project Leader is assigned. Tasks assigned as responsibility include all study start-up aspects.

Key Accountabilities

Project Initiation & Planning
Manages study start-up activities, in small or medium size studies
Provide input to project tools, PL project plan, Central File Maintenance Plan
Provide input to the format and content for sponsor reports
Provide input to and oversight of site selection strategy plan
Develop site selection plan for the team
Review and provide input into patient recruitment plan and retention plan
Ensure all team members have access to tools and documents
Establish efficient / effective working relationships with other functional Leaders and coordinators across geographies and projects within a given program
Develop study start-up plans, tools and forms
    Project Implementation, Control & Evaluation
    Provide Leadership and direction to study start-up project team members Identify, organize and deliver (where appropriate) study specific training in collaboration with PL and PS
    Evaluate and identify resourcing needs during the start-up phase of the project
    Provide productivity targets to study start-up project team members
    Provide performance feedback on team members as appropriate
    Address identified and escalated site issues and drive to closure
    Early recognition of areas of potential problems and provide input to contingency plans
    Monitor study timelines, patient recruitment and retention to ensure successful outcome of the FPI and LPI milestones of the project
    Oversee maintenance and quality check of CF until all sites are initiated
    Maintain and assure quality of work generated and escalate and follow up as appropriate Ensure appropriate handover between project team members Implement and instigate process improvements within the project
    Provide input to the Revenue Recognition forecast during the start-up phase Identify changes in scope and liaise with Project Leader
    May be required to visit site(s) as per client or project demands
    Participate in client, investigator and team meetings
    Prepare, participate in and follow up on audits / inspections
    Participate in all required applicable trainings
      Relevant Work experience in clinical research
      Competent in written and oral English
      Substantial experience in clinical research including relevant experience as a team Leader in Clinical or Study Start-Up functions or proven experience in coordinating clinical trials
      Degree in a life science, nursing qualification or relevant experience
      Experience in Coordination of Clinical Trials ' Preferably as Associate Study Start-Up Leader or proven experience in a similar role.
      Munkavégzés helye: Budapest

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