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ICON Clinical Research Manager, Project Management- Laboratory in Sofia, Bulgaria

At ICON, it’s our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

As a Snr Project Manager Laboratory, you will ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories services, including the setup and day-to-day management of studies.

The role

  • Act as the sponsor's main contact person in all matters regarding our central laboratory services,

following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON internal departments.

  • Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).

  • Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study Project Management Plan

  • Ensure adherence to the protocol specific monitoring plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained. Ensure that all necessary documents are archived at study closure.

  • Provide Sponsors with study management reports as required and agreed. Provide client with support on ICOLabs and iSite systems.

  • Proactively monitor study budget through monitoring of Protocol Tracking reports and other tools provided to assist

  • Regularly use the PM Dashboard to help monitor study progress and communicate to Sponsors in a timely manner if issues identified may require further investigation

  • Set the timelines for and monitor the progress of shipment requests for storage samples and verify data.

  • Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting, Bid Defenses or Face to Face Governance meetings.

  • Serve as a leader, mentor and consultant to more junior team members in resolving issues or

questions as they arise.

  • Serve as a gateway for escalation of PM issues to PM Manager and Senior/Executive Management

What you need

  • In depth proven experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life sciences related organization

  • Prior relevant experience successfully performing a Project Management role in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture.

  • Successful management in providing technical services for multiple clinical trials, including Presentation at Investigator Meetings, Implementation of protocol amendments, Completion of Laboratory Configurations, Trial reconciliations, Participation in sponsor/regulatory audits, Bid Defenses

  • Bachelor's degree or local equivalent in Science, Business or related Field and/ or an alternative combination of experience, education, and training.

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