Allergan Mgr, CMO Trial Management in Irvine, California
Mgr, CMO Trial Management
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/5370/other-jobs-matching/location-only
6 days agoPost 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.
Under supervision of the Chief Medical Office Trial Management (CMOTM) Team Lead and applicable Strategic Lead (e.g. Medical Director, Epidemiologist, HEOR Lead), the Manager is responsible for the execution of assigned clinical trials or non-interventional trials conducted within the CMO organization.
The position will be based in Irvine, CA
Ensures operational execution of CMO trials, interfacing as required with CMO personnel, Epidemiology, Safety, Biostatistics, Legal, Regulatory, Clinical Supply, Clinical R&D and other functional lines, as applicable
Drives study execution from planning, start-up, maintenance, reporting to close-out activities.
Selects and manages activities of contract research organizations (CRO) and other appropriate external study execution partners. Provides accurate trial cost and timeline forecasts based on assumptions provided by Strategic Lead
Manages trial expense within agreed upon trial budget paramete
Analyzes program productivity by tracking performance against quarterly budget forecasts and agreed upon milestones.
Maintains a high degree of awareness of assigned trial status, costs and timelines.
Provides study updates upon request to business partners and as required by CMO leadership and Strategic Lead.
Maintains updated trial records in electronic clinical trial management system (CTMS) and other required systems.
Maintains current scientific knowledge relevant to assigned therapeutic areas.
Maintains and demonstrates currency with all applicable Allergan policies and Compliance requirements as well as Good Clinical Practice (GCP).
Main Areas of Responsibilities
Responsible for the operational execution of assigned CMO studies.
Ensures study execution is consistent with product strategy and corporate compliance guidance. Provides due diligence of CRO capabilities and manages relationship with external vendors in successful completion of research programs.Manages development of clinical data by conducting prospective clinical trials and nonintervention observational studies. Coordinates study-related activities with internal stakeholders and partners to initiate and successfully complete studies with the goal of highest clinical science and integrity and for the maximum benefit of the company.Tracks programs against plans and benchmarks productivity.Provides accurate and timely budget forecasts as required for assigned trials.
Adheres to GNP standards for the conduct of trials.
Participates in activities, special projects and assignments as required. Maintains a customer focus that includes effective working relationships with internal and external study stakeholders, including CMO personnel and allied Allergan departments.Coordinates and supports publications and required registry postings.Proactively and reactively communicates trial updates and challenges to stakeholders.Maintains a strong connection with investigator sites.
Establishes and maintains currency with all required Allergan, GCP, and health authority policies and procedures.
Demonstrated technical skills and with understanding and conduct of clinical studies
Solid communication skills, both oral and written, with ability to effectively present to audiences of varying levels
Demonstrated ability to work effectively in a matrix environment
Demonstrated ability to work with others in multiple time zones
Demonstrated ability to manage multiple projects
Demonstrated understanding of and adherence to compliance
Ability to travel up to 5%
Prior experience in clinical research study management and/or site monitoring.
Global experience preferred .
- BS/BA Degree in Science or health-related field preferred with minimum of 3 years ORMS with minimum of 1 year of pharmaceutical industry or related health care research/education/marketing experience
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.