Allergan Mgr, Clinical Trial Management in Irvine, California
Mgr, Clinical Trial Management
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/5384/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.
The Clinical Trial Manager (CTM) is responsible for the operational execution of assigned clinical study(ies). Depending on the experience of the incumbent, they may be assigned as the Operations Study Lead (OSL) of a small study.
Main Areas of Responsibilities
The incumbent ensures the assigned clinical study(ies) is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
Responsible for all regional study management aspects of a clinical study.
Participates in all relevant and required SOP and in-house training seminars.
Responsible for ensuring that all direct reports’ training is current for therapeutic area, Allergan SOPs, GCP and local clinical research guidelines/laws.
Accountable for the development plans for direct line reports.
The incumbent will be responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate.
Responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events.
Documenting key communications from internal or external sources in the study file is required.
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 to maintain a solid knowledge base for performing assigned tasks.
Knowledge of Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
Through understanding of the clinical research and drug developmentprocess.
Ability to travel up to 25%
Significant pharmaceutical industry or clinical development/medicine experience
Previous experience of site monitoring and study management preferred
- BS degree in the sciences is required
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.