Clinical Trial Manager
hace 1 semana
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.What you will be doing:
Working fully embedded within the local clinical team in Spain, the Clinical Research Manager plays a key role in the success of global clinical trials at a local level.
The tasks undertaken are varied and can include:
- Accountability for the performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- To be the Country point of contact (POC) for assigned protocols and proactively drive/track execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles.
- Forecasting country resource needs and serving local business needs (sign contracts, manage budgets as delegated)
- Responsibility for quality and compliance of assigned protocols in the country and oversee CRAs and/or CTAs and training compliance.
- Performing quality control visits, reviewing Monitoring Visits Reports and escalating performance issues and training needs to functional vendor and internal management as needed.
- Responsibility for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners.
- Overseeing country and site validations, site selection, and recruitment in assigned protocols.
- Responsibility for clinical trial education to sites and act as the country POC for programmatically outsourced trials for assigned protocols.
- Representing the client in Pharma industry issues and in seeking influence in external R&D environment.
- Collaborating internally local Pharmacovigilance and Regulatory Affairs to align on key decisions in countries.
- Supporting local and regional strategy development consistent with longterm corporate needs in conjunction with Regional Operations
You are:
To enable success in this position you will have:
- A previous track record of success in a Clinical Project Management or a Clinical Research Manager role in a pharma company or global CRO ( 2-3 years of experience).
- Strong understanding of startup activities, clinical trial planning, (site) management and metrics.
- Strong communication and leadership skills
- Ability to coordinate and lead local teams to high performance and to lead across several dimensions simultaneously.
- Experience with therapeutic areas like
Hematology, Oncology recommended. - Hight level of english
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.
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