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Study Start-Up Project Lead, Bulgaria

Job Field:
Regulatory and Drug Safety Jobs
Regulatory Affairs Jobs
Bulgaria All
Contract Type:
1 to 2 per annum
Salary Description:
Inventiv Health
Job Ref:


Study Start-Up Project Lead, EMEA


Home or office based



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

inVentiv Health: Work Here. Matters Everywhere.

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.


* 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


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%)


* 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

To find out more about our company and search and apply for other open jobs please visit our website

inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment.

Closing Date:

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