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Associate Director Monitoring Excellence & Site Oversight

Company Name:
Absolute Opportunities
Title: Associate Director Monitoring Excellence & Site Oversight
Date Created: 05-23-14 (10:25 AM)
Location: Whippany, NJ
Openings: 1
The primary responsibility of this role, as Associate Director Monitoring Excellence & Site Oversight is: Responsible for the performance management of external service providers and an active member in CRO selection meetings.
Responsible for quality evaluation of a pool of preferred suppliers for clinical services, and sites with the necessary capabilities to provide all clinical services required globally in all TAs.
In close liaison with the OPLs/ECLs/CPLs proactive evaluation of new sites/CROs in their respective region to avoid resource and/or feasibility constraints.
The incumbent will:
The position is responsible for the performance management of external service providers and an active member in CRO selection meetings. Responsible for quality evaluation of a pool of preferred suppliers for clinical services, and sites with the necessary capabilities to provide all clinical services required globally in all TAs. In close liaison with the OPLs/ECLs/CPLs proactive evaluation of new sites/CROs in their respective region to avoid resource and/or feasibility constraints
Provide process excellence for monitoring and site management activities performed by external service providers to ensure patient safety and adherence of the sites to GCP, handling of corrective actions and preventative actions (CAPA)
Ensuring across study evaluations of external providers and sites, definition and tracking of KPIs per provider/site
Providing dedicated expertise for all StMs to support their relation to external service providers, primary point of contact for topics regarding external supplier/sites with regard to performance/KPI review
Ensure that the investigational site is also considered as a key customer for all process, tool and training initiatives
Define appropriate key performance indicators that can be used for monitoring and site management to best measure and assess the processes in place, in terms of time, cost, quality
Responsible for maintaining an up to date knowledge of new laws/regulations for the specific region in order to evaluate their potential to impact on planning/execution of monitoring and site management processes. Making recommendations for the next steps based on the evaluation
Build relationships with the global monitoring organization in the respective region and leverage synergies in country/region specific expertise by providing special expertise on early exploratory as well as HV trials
Work closely with the OPLs as well as the StMs to implement training needs assessments within the CRA and site staff. Support the development and delivery of training materials and strategies to ensure the training needs are fulfilled at the sites. Ensure cross cultural, regional requirements are considered
Drive the focus and implement measures to ensure the data quality at the sites. This may include, but is not limited to assisting in the implementation of CAPA and oversight strategies
Provide regional expertise for global CS studies
Provide center of expertise for all processes related to monitoring and site mgmt., represent CS in all global teams working on these topics.
The selected candidate is required to possess the following:
The successful candidate holds a university degree in science or a medical degree (i.e. study of medicine or study of natural sciences) or an equivalent qualification obtained through long lasting work experience
6+ years of study management, project management and/or clinical monitoring experience
Long term knowledge of processes, roles and responsibilities within clinical sciences study management
Deep knowledge of all national and international guidelines and regulations in the field of clinical studies, with special focus on the respective region
Fluent in written and spoken English
In depth knowledge of working principles in pharmaceutical industries as well as CROs
Ability to identify complex problems and find flexible solutions
Needs to work in a team orientated manner, able to build high performance teams
Process and results driven as well as a team oriented thinking and working
Effective communication, leadership skills, talent in organization and planning.

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