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Director Global Study Management Thousand Oaks United States,  

Posted on : 07 May 2017

Project Description

The Project Resource Management Director in Global Clinical Project Management responsible for the timely provision of Clinical Trial Management staff, trained and cost effective resources through internal and partner capabilities. The role is expected to be a rotational role, as such the successful candidate is capable of rotating into a Global Clinical Program Management Director role that leads protocol deliveryLead resourcing, staff management, training and standardization of staff in Global Clinical Program Management (GCPM)Lead GCPM resource planning and respond effectively to changing prioritiesLead departmental sourcing and FSP managementProvide input in to and manage departmental budgetsEnsure operational efficiency and compliance with R&D standards and training requirementsSupport continuous improvement initiatives in GCPM and throughout Global Development Operations (GDO)Responsible for:Providing global or regional input to the GSM TA departmental budgetLine management of Senior Manager, PRM staff globallyHire, manage and effectively allocate study management resources to meet project needs across whole departmentMentoring staff, ensuring staff development and ensuring awareness / standardization of current operating procedures and best practicesThe role-based curriculum for GCPMRepresenting GSM on process improvement initiatives, Development standards authorship or reviewKey ActivitiesResource the GCPM Clinical Trial delivery roleOversight of Functional Service Provider and deliverablesLead people management, career development, training and succession planning of GCPM staffIdentify training / staff development needs for GCPM and oversee implementation of training plansConduct performance management and performance reviews for senior manager, PRMIdentify areas for process improvement within GCPMLead / provide input into departmental budgets, headcount, hiring and resourcingLead the development of the GCPM role based curriculumLeads the functional core skills training program and ensures deliveryLead capability assessments for new corporate partners or FSP vendorsParticipate in vendor evaluation and management, represent GCPM at Operational Management Teams (OMT)Manage functional goal settingFacilitate sharing of best practices and product knowledge within the functionContribute to development and maintenance of policies, SOPs and associated documentsRepresent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and executionContribute to capability assessments for new vendors and participate in vendor qualification assessmentsDecision Making AuthorityFinancial approval consistent with gradeDepartment budgetGCPM resourcingDepartment role-based curriculumRecruitment and development of GCPM staffKnowledge:Knowledge of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reportingStrong external provider management experience, working with CRO partners.Project and Program management including oversight of study deliverables, budgets and timelinesTime, cost and quality metricsRelevant operational expertiseUnderstanding of resource management and organizational capacityExperience in developing goals and training plans to maximize talent and career development of staffExperience of managing projects in a matrix organizationAbility to network and build relationships to maximize organizational function and capabilitiesExperience in leading organizations through changeCompetencies:Departmental LeadershipPeople ManagementProject ManagementStrategic Operational PlanningRelationship Management and negotiation and influencing skillsInnovationDecision MakingConflict ManagementWritten and Oral CommunicationScientific / Technical ExcellenceFinancial ManagementFlexibility / AdaptabilityBasic QualificationsDoctorate degree and 4 years of Global Clinical Project Management experience ORMaster s degree and 8 years of Global Clinical Project Management experience ORBachelor s degree and 10 years of Global Clinical Project Management experience and 4 years of direct managerial and/or leadership experiencePreferred QualificationsM.D., D.O., PhD, PharmD, MSc11 years  work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO companyPrevious management experience of direct reports, including management level staffExperience at or oversight of outside clinical research vendors (CRO s, central labs, imaging vendors, etc.)Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.


US, California, Thousand Oaks

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