Allergan Assoc Dir, Study Start Up Management in Jersey City, New Jersey
Assoc Dir, Study Start Up Management
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/461/other-jobs-matching/location-only
▾ ▸ 1 additional location
Irvine, California, United States
Sep 08, 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.
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.
Responsible for overseeing global, cross-functional site start-up activities, supervising direct reports (as required) to ensure activities and tasks are performed appropriately and in compliance with all Allergan policies and procedures.
Main Areas of Responsibilities
Operational, cross-functional oversight of study/site startup activities and deliverables within specified therapy areas (or as delegated):
Partner with key stakeholders to oversee startup milestones, maintain alignment with clinical program timelines and business objectives, and focus on critical path activities.
Facilitate discussion of overall start up strategy, risk assessment, and contingency planning at a therapeutic area level.
Drive and proactively oversee business deliverables towards designated target Start Up KPIs.
Delivery of routine, transparent start up/activation updates and reporting.
Identify opportunities for increased efficiency and/or cost savings by maintaining oversight across assigned therapeutic area (or as delegated).
Responsible for interpretation of industry/regulatory/corporate guidelines relative to their effect on existing functional processes for global start-up.
Stay current with pharmaceutical industry GCP/ICG as it relates to governing compliance for essential document collection.
Maintain operational oversight of assigned Study Startup Specialists in all aspects of the Start Up Essential Document activities and CTA deliverables:
Oversee all processes for the collection and processing of study site documents from study startup through the lifecycle of the trial/program.
Responsible for Talent Management & Development of Direct Reports (as appropriate):
Supervise, mentor and evaluate performance of the Study Startup/Essential Document specialists as assigned.
Ensure development plans are in place for all direct reports.
Excellent knowledge of GCP, ICH and essential requirements for clinical trials.
10 or more years supporting global organizations in clinical operations or clinical development.
5 or more years in Clinical Program/Project Management.
Demonstrated operational and/or tactical experience in Study Start Up.
Must possess excellent skill/ability in the following:
Oral and Written Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
Initiative and Accountability
Promoting Innovation and Process Improvement
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, Microsoft.
Project and Adobe Acrobat Professional. Experience with Microsoft Access is a plus.
Field or office position with occasional travel up to 25% both domestically and internationally.
Supervisory / management experience preferred.
Global study management experience preferred.
Six Sigma, TQM preferred.
Bachelor’s degree in Business, Life Sciences, or other applicable field.