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Job Details

Study Start-Up Project Lead, EMEA

Company: inVentiv Health Clinical
Location: Romania
Reference: 15378
Closing Date: 24 Aug 17
Type: Permanent
Salary (£): 0 - 20,000
Benefits: negotiable

Job Summary:

15378Study Start-Up Project Lead, EMEAEuropeHome or office basedPermanentSummary:Here at inVentiv Health Clinical we are currently recruiting for a Study Start-Up Project Lead to be based in Europe.Job Details:As Study Start-Up Project Lead you would provide leadership to Study Start-up employees at the project level and would be accountable for achieving site activation in terms of quality, time and budget. ...

Requirements:

15378

Study Start-Up Project Lead, EMEA

Europe

Home or office based

Permanent

Summary:

Here at inVentiv Health Clinical we are currently recruiting for a Study Start-Up Project Lead to be based in Europe.

Job Details:

As Study Start-Up Project Lead you would provide leadership to Study Start-up employees at the project level and would be accountable for achieving site activation in terms of quality, time and budget. The position covers activities at the project level with direct oversight on business contributors working in simple project team structures.

Responsibilities:

* Develop and deliver project level study start-up training, start-up plan, and coordinate deliverables from all stakeholders who participate in start-up activities
* Review and approve study start-up documents which include sending for final approval for drug release
* Manage the maintenance of CTA, EC and central IRB submissions throughout the study and oversee the site contracting function via Site Contract Lead/Associates
* Support development of and present study materials at investigator/study launch meetings when required
* Ensure efficient distribution of workload and site assignments within the team
* Participate in business development proposals, defense meetings and proposal development
* Ensure quality of the start-up deliverables within a project and maintain proper visibility of its progress by the use of tracking tools
* Ensure efficient dissemination of information across the Study Start-up team within the project
* Interact with clients and other functional departments related to start-up activities and deliverables
* Ensure alignment of activities to budget
* Support the identification of study start-up out of scope activities, including supporting the completion of the start-up aspects of change orders
* Act as project manager on regional studies with limited scope of work (study start-up)
* Oversee CTA activities where they are related to start-up deliverables

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:

* 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%)

Benefits

* Competitive remuneration package with excellent benefits
* Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* Opportunity to work within a successful and rewarding environment.

Application Details

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

Apply for this job: Study Start-Up Project Lead, EMEA

Contact Information:

Address:  Main Office
Thames House, 17-19 Marlow Road Maidenhead, Berkshire
SL6 7AA, UK
England
Reasons to work for inVentiv Health Clinical
Tel:  +44 (0) 1628 408 408
Website:  Visit Our Web Site

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