Allergan Assoc Dir, Clinical Trial Management in Irvine, California
Assoc Dir, Clinical Trial Management
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/5451/other-jobs-matching/location-only
May 22, 2018Post Date
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 pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective 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 every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The Associate Director is responsible to lead and drive clinical operations for their assigned global clinical studies/programs and to ensure the global clinical studies/programs are executed to support the successful registration of new products/indications.
They will manage resources, training and budgets for their GCTM teams. They will provide input to the operational strategy and into key documents eg, study protocols and designs to ensure studies are operationally executable. They will ensure clear communication to senior management on operational updates. They will contribute to the DDO operational development by providing input and leadership in processes and working practices so that a continuous clinical quality process improvement is ensured.
Main Areas of Responsibilities
Responsible for: ensuring global study feasibility in collaboration with the FACT team and Regional CTMs for global studies-summarizing regional allocation of patients and resources; initial assessment of vendors needed; and the development of study specific documents and timelines.
Initiates 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.
Lead global IMP supply management; study enrollment management/tracking (e.g. contingency planning and implementation); global vendor management; global budgetary management; trial master file management; periodic review 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 all documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.
Developing the operational strategy/execution plan for a clinical program and is responsible for all program management aspects of a global clinical program. For all the global program activities, the incumbent will work with the OSLs and CTMs to ensure the global program is executed on time and to budget. The incumbent may also be asked to participate as a Global Clinical Trial Representative in cross-functional teams such as Protocol Review Team, Case Report Form Review Team, Clinical Study Report Review Team, and the Medical Safety Monitoring Plan Review Team.
Line management of 1 or more study managers.
Responsible for reporting any potential GCP violations either internally or externally as well as reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events.
Documenting key communications from either internal or external sources in the study file.
The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.
Minimum 10 years applied professional work experience; coupled with significant experience in Pharmaceutical / Medical Device development and people management
Early and late phase, and therapy area experience is an advantage
Thorough understanding of ICH Good Clinical Practices, global clinical trial management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas.
Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research studies.
Good understanding of drug development process, including preclinical.
Demonstrated understanding of risks to CROs’ businesses and how they might be impacted by Allergan.
Ability to travel up to 30% of time
- Bachelor’s degree required; concentrations in life science or health-related field preferred.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.