Ref #: 32629

Employment type: Permanent - Full-Time

Location: Germany, Home Based

Posted: 29-Sep-2021

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.



The Role:

For one of the most successful global players in the pharmaceutical industry ICON is hiring a Study Start-Up Solutions Lead (m/f). In this position the role holder will focus on one start-up area of responsibilities for periods of time and/or be working across the startup activities.

Key responsibilities:

• Collaborate with internal and external business partners for country protocol feasibility (if applicable) and site feasibility assessment.
• Drive the development of the Country & Site Activation Strategy Plan at study level across Phase I-IV, with internal and external business partners.
• Serve as the point of escalation to study teams for start-up process issues and facilitate resolution to issues identified.
• Evaluate translation procedures and strategies to accelerate regulatory submissions & site activations.

• Accountable and perform regular review of start-up performance and quality metrics at portfolio level and identify trends/gaps within the start-up processes, which may impact key deliverables (eg. timelines/ quality/costs) and work closely with internal stakeholders and/or external partners to ensure action or mitigation plans are defined and implemented at a program level.

• Drive the development of Master ICF/s and subsequent amendments, in Phase I-IV studies, with internal and external business partners, in accordance with the requirements of quality, ethical and regulatory standards.

• Drive with internal and external business partners, in the development of the CSA Strategy Plan at study level across Phase I-IV, that is in line with Country and Site Activation Strategy Plan.


To be successful in the role, you will have:

• At least 8 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment.
• Understanding of the overall clinical development paradigm, especially in the area of clinical study operations and have global or regional experience.
• Performed subject matter expert roles, especially in start-up activities.
• Experience in oversight of external service providers
• Experience in multiple Therapeutic Areas.
• Ability to work independently on assigned tasks or projects of increasing complexity.
• Excellent project, stakeholder and change management.
• Strong communication skills -verbal, written and listening in English


What is offered:

• Permanent Contract in one of the leading global CROs
• Full time, Home Office
• Great pipeline of studies
• Sponsor dedicated, working for one of the top 4 global players in the pharmaceutical industry
• Contribution to pension scheme


Benefits of Working in ICON:

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.

At 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.

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, color, 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.

Would you like to know more? Please submit your CV to timo.kindermann@docsglobal.com or via our homepage www.ICONplc.com. We are looking forward to your application.
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