3199 Global Studies Manager II
DESCRIPTION:
As a Global Studies Manager (GSM), 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.
HOW YOU WILL DO IT:
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, embracing diversity and creating a culture of inclusion 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 the Company’s values in everything you do.
SKILLS
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.
Have a minimum 3 years of relevant experience (clinical trial management is a plus).
Hold a university degree or equivalent years of experience, preferred focus in life sciences.
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.
Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.