Clinical Study Manager - Neurology in Irvine, CA

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Matthew Masterson
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Clinical Study Manager - Neurology in Irvine, CA

 About Allergan: 

Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life?s potential. Today, we have 11,400+ employees highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. 

About the Position: 

The Clinical Study Manager will ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans. In particular they will align operational execution activities with agreed upon project priorities, timings and quality specifications and adhere to all relevant regulations including GCP, ICH and PhRMA guidelines, regulatory requirements, and Allergan?s SOPs and policies. 

The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole. 

Principal Responsibilities: 

Global Study Manager 

The incumbent will be responsible for all study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the global study activities, the incumbent will work with the Regional Study Managers (RSM) to ensure correlation of global study activities. 

Study concept, planning and strategy phase 

The incumbent is responsible for: ensuring global study feasibility in collaboration with RSMs (if global study) and summarize regional allocation of patients and resource; initial assessment of vendors needed; and the development of study timelines. 

Study Initiation Phase 

The incumbent is responsible for: global essential document development (e.g. study level consent forms, advertising materials), and study deviation specifications; assessing global vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of global enrollment initiatives and budgetary planning; planning clinical study supplies; review and approval of data management plan. 

Study Management/Conduct Phase 

The incumbent is responsible for: global IMP supply; study enrollment management/tracking (e.g. contingency planning and implementation); global vendor management; global budgetary management; trial master file oversight; ongoing management of protocol deviations; ongoing review of study data and data cleaning process. 

Close-Out Phase 

The incumbent will be responsible for: review of CSR shells; review of CSR and assembly of appendices; database lock activities; finalization of the study protocol deviations repository; ensuring that the study close out activities are completed; ensuring study documentation is properly archived when the study is considered completed 

General 

The incumbent may also act as the Program Operations Lead (POL) for a project. 

Regional Study Manager (RSM) 

The incumbent will be responsible for all regional study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the regional study activities in a global study, the incumbent will work with the GSML to ensure correlation of global study activities. 

Study Concept, Planning and Strategy Phase 

The incumbent is responsible for: ensuring regional study feasibility in collaboration with the GSM including summarizing regional assessment of patients and resource; initial assessment of vendors needed; and the development of regional specific study timelines. 

Study Initiation Phase 

The incumbent is responsible for: region-specific document development; assessing local vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of regional enrollment initiatives; input any regional specifics to the global study budget via the GSM; planning regional clinical study supplies. 

Study Management/Conduct Phase 

The incumbent is responsible for: regional investigator meetings/presentation of materials; regional financial management; database lock activities; regional study drug management; regional trial master file; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; ensuring compliance of serious adverse event reporting. 

Close-Out Phase 

The incumbent is responsible for: supporting database lock activities; ensuring all regional documents are filed in the CSR sections appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed. 

Leadership and People Development 

Participates in all relevant and required SOP and in-house training seminars. 

Is responsible for ensuring that all direct reports training is current for therapeutic area, Allergan SOPs, GCP and local clinical research guidelines/laws. 

Is responsible for the development plans for direct line reports. 

Other roles 

Other roles may be allocated as appropriate to the incumbent as required to ensure delivery of the clinical studies. 

Program Operations Lead ? Assist Role to Therapeutic Operations Lead 

The incumbent is responsible for developing the operational strategy/execution plan for a clinical program. This includes but is not limited to: leading the Project Operations Team; leading project wide vendor selection (e.g. Central Reading Center); project wide clinical budgetary oversight; project feasibility and strategy for study(s) placement; project level audit readiness; project level tracking and information management; project level clinical supply forecast and oversight.

Requirements: 
* PhD/PharmD/MD/OD/DO with 4 years pharmaceutical industry or clinical medicine experience; minimum two years of clinical research/development experience or 
* Master's degree with 7 years pharmaceutical industry or clinical medicine experience; minimum four years direct clinical research/development experience or 
* Bachelor's degree with 9 years pharmaceutical industry or clinical medicine experience; minimum six years direct clinical research/development experience. 
* Experience of site monitoring is preferred 
* Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring), regulatory compliance (including individual global/country directives/regulations as necessary) and statistical reporting including demonstrated, ongoing application of these knowledge domains to current studies for which the CRM is responsible. 
* Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research studies. 
* Competencies and essential skills in the following: interpersonal relationships, communication, decision making, execution/results/process improvement, presentation, customer satisfaction, leadership, people and talent management
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