Senior Clinical Operations LeaderThe Senior Clinical Operations Leader is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Clinical Operations deliverables (timeline, quality, productivity) are met.
This position has overall accountability for the execution of the clinical operations strategy on the project.
May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.
This role is responsible for coordination of clinical team for a small to midsize project(s) and therefore acts as a role model and/or coach for the team.
This role can also be part of a global project management team.
Key Accountabilities:Client LiaisonEffectively communicate with internal and external customers as well as third party vendorsPrioritize effectively and respond to urgent requests within team or from sponsor.Project Initiation & PlanningManage study start-up activitiesProvide input to project tools, PL project plan, Central File Maintenance PlanProvide input to the format and content for sponsor reportsProvide input to and oversight of site selection strategy planDevelop site selection and monitoring plans for the teamReview and provide input into patient recruitment plan and retention planProject Implementation, Control & EvaluationProvide leadership and direction to project team membersEvaluate and identify resourcing needs and continuously monitor the use of resources over project life cycle of projectProvide productivity targets to project team membersEarly recognize areas of potential problems and provide input to contingency plansMaintain and assure quality of work generated and escalate and follow up as appropriateImplement and instigate process improvements within the projectOperationalMaintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedureQualifications:Substantial experience in clinical research including relevant experience as a Team Leader in Clinical functions or proven experience in coordinating clinical trialsExperience in Phase I Oncology experience advantageousDegree in a life science, nursing qualification or relevant experienceCompetent in written and oral EnglishSalary: €80,000 - €100,000 per year
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