Assoc Dir, Clinical Trial Mgmt - South San Francisco, CA | Biospace
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Assoc Dir, Clinical Trial Mgmt

Allergan, Inc.

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Location:
South San Francisco, CA
Posted Date:
6/22/2017
Position Type:
Full time
Job Code:
158800
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Clinical Trial Manager, Director,

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 Associate Director, Global Clinical Trial Management, will ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans. In particular, these strategies 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 policies and SOPs.

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. The employee must conduct their work activities in compliance with all relevant laws, regulations, guidelines, and Allergan policies and procedures.

Main Areas of Responsibility

Responsible for all study management aspects of a global clinical study including but not limited to all of the tasks specified below. For the global study activities, the incumbent will work with the Regional Study Managers (RSM) and Global Site Monitoring Lead (GSML) to ensure coordination of global study activities.

Study Concept, Planning and Strategy Phase

Ensures global study feasibility in collaboration with RSMs (if applicable) and summarize regional allocation of patients and resource; initial assessment of vendors needed; and the development of study timelines.

Study Initiation Phase

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

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

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

Executes the operational strategy/execution plan for a clinical program. This may include but is not limited to: leading project wide vendor selection; project budget 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. Participates in all relevant and require SOP and in-house training seminars.

Requirements


Minimum 8 years direct clinical trial management experience in the pharmaceutical industry and experience with management of staff and team management is preferred.

Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research studies.

Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring), risk mitigation strategies, trial budgets, site selection, clinical supplies management and regulatory compliance (including individual global/country directives/regulations as necessary).

Ability to travel up to 30% of time


Education

Master’s degree with 9 years’ pharmaceutical industry or clinical medicine experience.
Bachelor’s Degree with 11 years’ pharmaceutical industry or clinical medicine experience.