Allergan Sr. Study Management Associate in Irvine, California
Sr. Study Management Associate
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/947/other-jobs-matching/location-only
5 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 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.
Our success 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.
This position will assist the Global / Regional Study Manager in the operational execution of clinical studies. 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 complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.
Main Areas of Responsibilities
Ensure all site-related activities and files are completed per the SOPs.
Act as key point of contact for study specific questions from both internal (site monitors, clinical services specialist) and external (site personnel, vendors) customers.
Facilitate communication across departments and elevate site and study issues as appropriate.
Support study feasibility activities, participate in site selection process and work closely with Site Start Up group.
Prepare, collect, and track master study level documents and site non-regulatory documents, as needed.
Reconcile and submit essential documents to TMF. Report discrepancies to the appropriate clinical team member in a timely manner.
Track and assist with processing site/vendor payments. Follow up on any issues as required.
Collect and track patient enrollment information and update study management reports as necessary.
Support the monitoring team and study sites with relevant study information.
Responsible for collecting and tracking study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.
Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.
Assist senior team members with in the planning, preparation, and on-site support of investigators meetings. May be responsible for presenting clinical operations training.
Generate reports in various applications to assist the Clinical Scientist to perform clinical data review as needed.
Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.
Support the Regional Site Managers (RSMs) by providing study related information and supplies, as requested.
Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.
Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).
Contribute to process improvement efforts including task forces and committees as needed.
Support clinical team with requests from management as needed.
May deliver training related to day-to-day responsibilities for new Clinical Trial Assistant (CTA) hires within department.
May contribute to tracking budgets as needed.
Support document filing and organizing as needed. Coordinate and process office supply orders.
The following listed requirements need to be met at a minimum level to be considered for the job:
Bachelor's Degree or higher, preferably in science or health-related field
4+ years clinical study research experience in pharmaceutical industry or CRO.
Good Clinical Practices, ICH guidelines, ISO 14155, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations).
Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
Strong skills with Microsoft Excel
Ability to manage multiple tasks
Preferred Skills/Qualification s
Experience supporting clinical trials preferred. Medical device experience is a plus
Experience using electronic data capture (EDC) systems is a plus