Ref #: 31651

Employment type: Permanent - Full-Time

Location: Germany, Home Based

Posted: 22-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 DOCS is hiring a Global Clinical Trial Lead (m/f). If you have experience in and want to develop further into global Clinical Trial Management from a sponsor’s perspective and by doing so, helping to improve treatment of today’s biggest challenges to public health, than this might be for you.
In this role you are responsible for planning, coordinating, preparing and conducting complex global clinical trials, including the budget within assigned therapeutic area(s).



Key responsibilities:

• Uses specialist knowledge, advanced analytical skills, judgement, broad conceptual and practical experience to solve complex problems and contribute to process improvements.
• Effective leader, ability to identify and resolve technical, operational and organizational problems with high complexity.
• As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals and objectives of the Clinical Operations Team and/or Global Program Team.
• Leads the execution of clinical phases of assigned global programs across all phases (Phase 1‐4) including post‐marketing commitments and Biosimilars.
• Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies.
• Develops and leads the presentation on trial status to Integrated Clinical Study Committee and other relevant committees for deviations from budget and timelines as needed, highlighting issues and risks.
• Qualifies operational feasibility and establishes and analyzes protocol‐level budget and grants throughout the life cycle of the trial.
• Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning.
• Drives oversight of CROs and vendor management at trial level according to the applicable partnership model.
• Understanding of trial feasibility elements and understanding of regulatory requirements across countries.

To be successful in the role, you will have:

• Preferred substantial professional experience (approximately 6‐8 years as a guide) in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least three (3) years of them in clinical trial management.
• Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report.
• Proven track record of having successfully led one or more multinational trials.
• Solid leadership, problem solving, planning and organizational skills.
• Ability to build trusting and collaborative relationships that promote innovation, knowledge‐sharing and adaptation to change.
• Fluency in English (oral and written).
• Position requires both domestic and international travel up to 30% of time.



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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