Study Start-Up Project Lead
Home or office-based across EMEA
An excellent opportunity to join a rapidly expanding CRO being a core part of the Global Study Start-Up Team. You will deliver unique results by acting as the primary point of contact for GSSU, planning and facilitating global study start-up process as well as coordinate site identification and site contracting activities. We are keen to hire a talented Study Start-Up Professional with experience in the Pharmaceuticals/ CRO industry to be located in Europe.
* Assist with proposal development and represent GSSU in bid defenses
* Compile study start-up documents specifically related to Institutional Review Board and/or Ethics Committee (EC) submissions per country regulations
* Develop GSSU strategy including timelines, and write GSSU plan
* Review scope of work and request resources as applicable
* Customize core documents as well as develop, report, and maintain GSSU tracking
* Attend meetings as GSSU primary point of contact
* Contract hand off meeting
* Attend Client kick off meetings, Project Team meetings and Investigators' Meeting
* Liaise with Sponsor and the Project Team
* Review and approve study start-up documents as appropriate
* Maintain EC and central lRB submissions throughout the study
* Review and analyze metrics (and budget) to ensure consistency and project deliverables are on target
* Coach, mentor, and provide training for Team Members
* Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
* Extensive Global Study Start-Up experience with approximately 15 studies started-up, or equivalent experience
* Strong regulatory background and experience combined with solid leadership and project management skills
* Ability to effectively communicate and interact with Sponsor and Project Team
* Ability and willingness to travel
There are many benefits available to employees of inVentiv. They include competitive compensation and benefits (details on request).
If you have the required experience for this position and are eligible to work in the required location then please apply by CV or contact Magdalena Raczyńska on
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.