Allergan Mgr, Clinical Trial in Madison, New Jersey
Mgr, Clinical Trial
Madison, New Jersey, United States at https://agn.referrals.selectminds.com/jobs/7378/other-jobs-matching/location-only
Nov 29, 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 incumbent is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Allergan departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be assigned as required.
Main Areas of Responsibilities:
Ensures the assigned clinical study is run to time, budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
May participate as a Global Clinical Trial Representative in cross-functional teams such as Case Report Form Review Team and Clinical Trial Team.
Support and work with the FACT team to conduct study feasibility.
Responsible for the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required.
Responsible for supporting document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies.
Accountable in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor.
Support the following activities: database lock activities; 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.
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.
Accountable for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events.
Responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work Instructions.
Previous experience working on a clinical study
Ability to document all key communications from either internal or external sources in the study file
Ability to complete all required training in compliance areas to execute their job
Therapeutic specific knowledge is expected to maintain a solid knowledge base for performing assigned tasks
Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
Knowledge of concepts of clinical research and drug development, and
General therapeutic area education and training
Handle and prioritize multiple tasks simultaneously,
Work effectively in a team/matrix environment,
Understand technical, scientific and medical information,
Handle conflict management and resolution,
Understand clinical study budgets,
Plan, organize, project manage and analyze data, and
Demonstrate full competency in Microsoft Office programs.
- Bachelor's degree required preferably in science or in a health-related field
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.