Senior Clinical Study Manager

Organization
Allergan
Job Location
Jersey City, NJ
Job Description

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. 

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. 

Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right. 

Join one of the world's fastest growing pharmaceutical companies! 

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight. 

Join our bold team! Learn more at www.Allergan.com. 

Position Description 

The Senior Clinical Manager/Clinical 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. 

Main Areas of Responsibilities 

• 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. 

• 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. 

• 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. 

• 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. 

• 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. 

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

• 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. 

• 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. 

• 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. 

• 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. 

• 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. 

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

• Responsible for the development plans for direct line reports 

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

• D eveloping 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: 

Requirements 

• 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. 

• Highly skilled in Cross Functional Relationships 

• Excellent Communication Skills 

• Execution/Results/Process Improvement 

• Customer Satisfaction oriented 

• People and Talent Management 

• Decision Making and Facilitating Change 

• Finance/Budget Management 

• Organization & Industry Awareness 

• Strong Influencing & Team Leadership skills 

• Managing Conflict and Negotiation skills 

• Planning/Organization/Project Management skills 

• Results Orientation 

• Ability to Meet Challenging Milestones 

• Ability to problem solve independently & with others 

• 10-20% travel is required for this job. 

Preferred Skills/Qualification 

• Experience of site monitoring is preferred 

Education 

• PhD/PharmD/MD/OD/DO with 6 years pharmaceutical industry or clinical medicine experience; minimum four years of clinical research/development experience or 

• Master's degree with 9 years pharmaceutical industry or clinical medicine experience; minimum six years direct clinical research/development experience or 

• Bachelor's degree with 11 years pharmaceutical industry or clinical medicine experience; minimum eight years direct clinical research/development experience 
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