Global Studies Manager II

Employment Type

: Full-Time

Industry

: Miscellaneous



Title: Global Studies Manager II
Location: South San Francisco, CA
Description:12+ Months

YOUR FOCUS
You will be focused on molecules within one of our exciting therapeutic areas in Immunology, Infectious Diseases, Ophthalmology, Neurosciences (I2ON), having the opportunity to experience our multiple areas over time
This role will initially focus on: Onboarding, SOPs, systems, process training, and about the studies assigned to.
You will report to a Global StudiesLeader You will be recognized as a leader and work autonomously in a cross functional, global team

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. You will
•    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  values in everything you do


WHO YOU ARE
You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, rigorous and entrepreneurial spirit. You…
•    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

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