Senior Clinical Operations Leader

3 mesi fa

Milano, Italia Parexel International A tempo pieno

The 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.
The Senior Clinical Operations Leader 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 position 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 position 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 planEstablish efficient / effective working relationships with other functional Leaders and coordinators across geographieswithin a given programDevelop study plans, tools and formsProject 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 plansMonitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the projectMaintain and assure quality of work generated and escalate and follow up as appropriateImplement and instigate process improvements within the projectProvide input to the Revenue Recognition forecastIdentify changes in scope and liaise with Project LeaderMay be required to conduct site visits as per client or project demandsParticipate in client, investigator and team meetingsPrepare, participate in and follow up on audits / inspectionsProject Close-outCollaborate with project team (e.g.
Project Leader and Data Operations Leader) on database lock activitiesTogether with Project Leader ensure all administrative closeout procedures are completed, according to Project Close-out ChecklistTogether with Project Leader ensure project is archived and all documentation returned to the client as specified by the contractParticipate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functionsOperationalMaintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatoryrequirements and Parexel WSOPs, SOPs, Operational Guidelines, Work Instructions and study specific procedureComplete routine administrative tasks in a timely manner (e.g.
timesheets, metrics, office and travel expense claims)QualificationsSubstantial 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 EnglishStrong understanding of the cross functional activitiesLeadership skillsStrong customer focusAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailEffective time management in order to meet daily metrics or team objectivesPersonal skills that include: ability to take initiative and work independently, ability to successfully work in a team environment, sense of urgency in completing assigned tasksExcellent interpersonal, oral and written communication skillsExcellent presentation skillsAbility to travel as required #J-18808-Ljbffr

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