Senior Manager, Phase IV Studies (GMA Evidence Generation)

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Sr. Manager, GMA Evidence Generation will support evidence generation within GMA, across therapeutic areas.  This role will serve as the Business Owner and administrator for Teva GMA Evidence Generation systems. 

 

As GMA Business Owner you will:

• Support the oversight, processes, and governance of GMA led clinical studies, including local Medical Affairs sponsored studies.
• Support the Clinical Trial Management system and liaise with IT as needed. 
• Interact directly with internal and external stakeholders in order to ensure oversight of system operations, maintenance, releases, testing data entry and other system activates as needed. 
• Be responsible for maintaining policies, SOPs, Work Instructions and related supporting procedural documents essential for compliance as well as support of quality and inspection readiness initiatives.  (This will include identification of updates/needs, working within a team to communicate needs and preforming the technical testing and implementation as well as identification of and support testing, migration, and training for the new systems. )
• Interact directly with internal and external stakeholders in order to ensure the timely execution of assigned tasks.

 

Travel Requirements:  Minimal (limited regional and/or international travel)

How you’ll spend your day

• Serve as the primary focal point with IT for system testing, validation, data migration and support ongoing system management
• Be responsible for the development and implementation of the business requirements within the system in collaboration with all identified stakeholders – X6 releases per year
  • Develop UAT scripts
  • UAT execution and validation
• Develop and ensure training for new users, internal and external
• Represent GMA in the review and development of various procedural documents related to the clinical trial management system and other evidence generation platforms.
• Develop and track appropriate KPIs to ensure system meets expected requirements and monitor progress
• Interact  with Regional SMEs to understand pain points with system functionality, support business questions, communicate and work with the IT teams on system fixes to address issues
• Support report and dashboard development and adjustments
• Ensure smooth operation of the systems internal interfaces and vendors with high responsiveness and short time to issue resolution.
• Support quality initiatives including inspection readiness oversight for Medical Affairs Studies.
• Manage vendors to ensure accurate service delivery, required process or system updates and ensure continuous service/support.

Your experience and qualifications

Required Education

• Bachelor’s degree from an accredited college or university preferably in MIS (Management Information Systems), computer science, healthcare/bio-informatics , Biomedical Sciences, Pharmacy or similar area.

 

Required Experience

• 3 years of demonstrated experience in supporting and managing technology systems of clinical trials, experience with writing and executing UAT scripts, processes, and implementation of requirements.
• Strong interpersonal skills with experience in project management, organization and tools

 

Preferred Experience:

• Experience in working in a complex global environment
• Experience working with Veeva platforms
• At least 3 years in a research, clinical or healthcare setting

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance

Reports To

Director, Evidence Generation

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