Allergan Clinical Affairs Manager - R&D Devices in San Francisco, California
Clinical Affairs Manager - R&D Devices
San Francisco, California, United States at http://agn.referrals.selectminds.com/jobs/624/other-jobs-matching/location-only
Sep 26, 2016Post 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 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.
Oursuccess 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.
The Clinical Affairs Manager is responsible for managing all aspects of a clinical study to ensure the study is completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
Main Areas of Responsibilities
· Organizes and supports domestic and international clinical studies as they relate to Allergan products.
· Provides training to and oversight of all clinical trial team members including but not limited to Company and site team members, i.e. physicians, investigators, site managers, coordinators, etc.
· Learns and masters the set-up, use and maintenance of the Company’s proprietary device systems and procedures.
· Writes study protocols, designs case report forms and develops informed consent documents.
· Assists in the identification of clinical investigators and manages site selection.
· Manages the budgeting and contract aspects for the clinical studies on a site-by-site basis.
· Supervises and coordinates all clinical research personnel activities.
· Develops clinical monitoring plan for the studies.
· Oversees and performs clinical study monitoring.
· Manages the Institutional Review Board/Ethics Committee (IRB/EC) submission process for sites and assists when needed.
· Identifies and manages IRB/EC study activities.
· Prepares investigator training plans.
· Performs site initiation visits, clinical monitoring visits, and site closures as required.
· Manages the termination of trial sites.
· Prepares the final clinical study report with support from clinical programmer and biostatistician.
· Interfaces with various Allergan departments relating to clinical studies.
· Assists investigators in preparing presentation and publication materials.
· Provides periodic updates or reports of the current status of clinical trials to senior management.
· Assists in the creation, development, submission and pursuit of regulatory clearances both in the US and OUS.
· Assists as needed with Company non-clinical departments in meeting quality, regulatory, engineering, marketing and sales goals and objectives.
· Attends off-site medical conferences and Company meetings to increase knowledge, which will be of benefit in fulfilling these major duties and responsibilities.
· Extensive experience in clinical trial design and management (+5 years).
· Experience with medical writing (study protocol, informed consent and clinical study report).
· Two years or more at the Senior CRA level supervising or managing CRAs.
· Previous experience in the performance of multi-site human clinical trials.
· Knowledge of clinical study ethical standards (ICH, ISO 14155, tenets of the Declaration of Helsinki and FDA regulations).
· Working knowledge of medical office activities and routine.
· Good interpersonal skills with physicians, nurses and medical staff.
· Ability to work independently
· Previous experience working with CRO groups preferred, but not required.
· Knowledge of ophthalmology preferred, but not required
· Upper level course work in statistics, biology and other technical areas preferred, but not required.
· BS/MS in scientific discipline/medical technological or related health care field.