Project Manager
- Bulgaria, Czech Republic, Hungary, Poland, Romania, Spain
- Project Management
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
As a Senior Clinical Project Manager (Senior Study Delivery Lead) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
This is a permanent role employed through ICON and sponsor dedicated to our client (FSP). This is a home-based role.
Please note the countries we can consider are: Poland, Spain, Romania, Czech Republic and Bulgaria. You must already be located in these countries and have the right to work and live in these countries.
What you will be doing:
The Senior SDL has the accountability for 1 or several complex studies, and perform the full
set of activities of the Study Delivery Lead and has the ability and the seniority to manage the delivery of any types of studies, different areas, complex/unusual early setting, new/unusual indication, pivotal / Phase III and efficacy studies, clinical as well as epidemiology and local studies, complex countries/regional environment.
Accountabilities for study delivery strategy and execution:
Coordination of full feasible Study Protocol - In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination of full, feasible study protocol development that aligns to the CSP and CDP/IEP and can be feasibly implemented in the clinical and regulatory environment of participating regions to provide quality data and ensure timely study delivery Oversight of delivery quality - Lead escalation and resolution of any issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The Senior SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the absence of Asset Lead). In outsourced studies escalation points will include CRO suppliers - Maintain regular interaction with all study team members to ensure issues / risks / successes with study delivery are reviewed and/or shared as they occur. - In addition, in outsourced studies: o Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and CRO are aligned on delivery strategy o Embed a culture of empowerment and accountability for CRO to resolve study issues internally o Encourage CRO to take accountability for quality data delivery o Provide holistic oversight of CRO – understand study contribution to program/submission
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You are:
Experience required >8 years of significant experience in managing complex clinical research studies, clinical operations or equivalent
Has a very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements.
5 years of experience in regional clinical study leadership desirable
Strong skills and experience in project management and tools
In depth knowledge of GCPs and ICH guidelines
Excellent communication and presentation skills
Solid experience working in teams with a broad range of cultures including team leadership
- Oncology experience required
You must have the right to work and live in the countries you are applying for.
If you do not have Clinical Project Management experience within a CRO or Pharma environment, then we cannot consider your application.
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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