Global Study Manager

Posted 05 January 2022
Job type Limited
DisciplineScienceLife Sciences

Job description

For our client Roche in basel we are looking for a

Global Study Manager

Perfect Candidate:
The perfect candidate has a strong level of broad experience in running trials from the operational aspect (vendors, affiliate or CRO management, team work (and some budget experience useful). The candidates also need to be able to start working on studies immediately, there will not be much time for 'getting used to the work environment' etc.

Tasks & Responsibilities:
As a Global Studies Manager (GSM) at Roche/Genentech, you will lead or contribute to one or more cross-functional global working groups, expert squads, and global Study Teams, which deliver all operational aspects of one or more studies through all phases and stages.

  • DRIVE OPERATIONAL EXCELLENCE by developing operational plans, creating and managing clinical study budget and overseeing the consistency of operations
  • MANAGE VENDORS AND STAKEHOLDERS by managing relationships with vendors and cross-functional stakeholders. Oversee performance of vendors and third-party providers
  • LEAD AND INFLUENCE by establishing yourself as a leader within the team, being recognized as a thought leader who inspires others to perform at their best and learn from best practices. You'll be shaping our capabilities and evolving your role overtime
  • MANAGE RISK AND COMPLIANCE by developing site monitoring and risk mitigation strategies and ensuring your team adheres to all appropriate standards, including ICH/GCP and other regulations
  • PLAN DEMAND AND SUPPLY by overseeing the resource management, forecast and maintenance of supplies needed to ensure sites have the necessary supplies to run clinical studies
  • PROVIDE COUNTRY OVERSIGHT by leading feasibility assessments to ensure countries and sites are selected for participation in trials. Provide guidance to country operational reps during trials
  • You will succeed as a Global Studies Manager by leading, collaborating, and relaying your expertise to cross-functional partners.
  • Apply your good knowledge of drug development process and respective regulations, including ICH and GCP guidelines
  • Apply your organizing and problem-solving skills to plan and run efficient operational aspects of a study
  • Motivate others to deliver against commitments, including leadership of global teams across diverse cultures and time zones to ensure successful collaboration
  • Demonstrate agility and ability to perform in a highly fast-paced, matrix environment where cross-team collaboration is crucial
  • Leverage excellent verbal and written communication skills to motivate your team, negotiate with peers and partners and influence across stakeholders
  • Advocate for what you and your team need to succeed
  • Model Roche's values in everything you do

Must haves:

  • Minimum of 3/4 years in clinical trial management (working knowledge of drug development process and respective regulations, including ICH and GCP guidelines
  • Experience with budget management & oversight
  • Minimum Bachelor's Degree in Life Sciences
  • Have a growth mindset and are excited about learning through experience
  • Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments
  • A self-starter who finds passion in achieving successful outcomes by leading, directing and inspiring peers
  • Want to make a difference and find excitement in innovating practices, products and processes
  • You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, rigorous and entrepreneurial spirit.

Nice to haves:

  • immunology, infectious disease, or ophthalmology experience

General Information:

  • Start date: Asap
  • End date: 31.12.2022
  • Extension: possible
  • Work location: Basel
  • Workload: 100%
  • Remote/Home Office: onsite will be required. The exact amount will be discussed when the contractor is in assignment. Please note a certificate will be needed for onsite work.
  • Travelling: no
  • Department: Clinical Ops I2ON (MDGQN)

Your Application

Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).