Company: inVentiv Health Clinical
Closing Date: 14 Dec 16
Salary (£): Negotiable
inVentiv Health -Transforming Promising Ideas into Commercial RealityJob Title: Study Start-Up Project Lead, EMEA Primary Function: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. ...
inVentiv Health -Transforming Promising Ideas into Commercial Reality
Job Title: Study Start-Up Project Lead, 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
* Client kick off meeting
* Project Team meeting
* Investigators' Meeting
* Liaise with Sponsor and the Project Team (Business Development, Project Management, Feasibility, and other Departments as required)
* 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 Study Start-Up experience (preferably global), 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 (up to 40%)
In return we will offer:
* A competitive remuneration package with excellent benefits
* A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* The opportunity to work within a successful and rewarding environment
Location: EMEA, home or office based.
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries. We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market. For more information, visit inVentivHealth.com
We look forward to receiving your application!
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