Global Site Activation Lead II

Study Start Up France


Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

Success starts with a dedicated team of specialist supporting study and site activation, and we are seeking a Global Site Activation Lead to design and implement start up submissions strategies to help us advance research for patients in critical need.

As a Global Site Activation Lead on Premier Research’s Sites and Patients team, you will provide sponsors with strategic leadership to improve the start-up process. The Global Site Activation Lead works closely with assigned country-level Start Up team members to execute plans, ensuring delivery on time and on budget. The right person for this customer-facing role will feel empowered to creatively tackle problems and challenges.

Core responsibilities:

  • Draw on global drug development experience to develop and implement regulatory & start-up submission project plans, risk mitigation strategies, and draft submissions to boards/evaluating bodies as well as import and export licenses, where appropriate
  • Act as Sponsor liaison, addressing notifications regarding pertinent milestones, project timelines, potential risks, and contingency plans
  • Lead a team of assigned country-level Study Start Up team members in the execution of plans, ensuring quality delivery on time and on budget

What you’ll need:

  • 7+ years study start-up experience with at least 3 years in a global study start up role
  • Experience working on ample number of countries in global studies with a working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and start-up procedures
  • The ability to develop a collaborative team environment and maintain strong cross-functional relationships that enable effective and creative problem solving

Why choose Premier?

  • Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
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