Ref #: 30414

Employment type: Permanent - Full-Time

Location: Any location in Poland

Posted: 21-Jul-2021


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 Clinical Trial Manager will be responsible for leading the regional matrix team, including CRAs, CTAs and additional staff, to ensure delivery of country and site level study activities in alignment with the global study project plan.

Key Responsibilities include:
•Identifying and resolving issues at a regional level
•Collaborating with Global PM to ensure country level study delivery is aligned with the global study project plan
•Contributing to study-level risk assessments
•Leading and continually review regional risk mitigation activities to ensure study delivery to plan
•Overseeing regional insourcing /outsourcing partner deliverables to the required standards
•Partnering with Tech Services, Supplier Governance and Electronic Trial Operations to ensure regional, country and site vendor set-up, conduct and quality
•Leading regional documentation and required tool and systems set-up
•Contributing to regional aspects of Drug Supply Plan
•Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines

Critical Success Factors for the Role include:
•Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines
•Strong Knowledge of Clinical Development process and procedures
•Project planning experience including oversight of study deliverables, budgets, and timelines
•Ability to use scientific and clinical knowledge to conceptualize study designs
•Experience anticipating and resolving problems
•Experience writing and presenting clearly on scientific and clinical issues
•Experience collaborating and leading cross-functional teams (team /matrix environment)
•Knowledge of project risk management assessment and mitigation approaches

Requirements and Qualifications:
•BA/BS/BSc or RN
•At least one year of experience on the similar position
•General biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
•Previous management experience of direct reports
•Experience in oversight of outside clinical research vendors including CROs, central labs, imaging vendors, etc.

Key Competencies:
Project Management / Risk Assessment / Critical Thinking and Planning / Matrix Team / Organizational Leadership / Metrics Analysis / Strong Written and Oral Communication / Delivery Focus / Decision Making / Relationship Management / Conflict Resolution / Problem Solving / Adaptability / Flexibility / Working in Virtual Teams

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.

If you are an experienced clinical professional looking for an opportunity with a rapidly growing and fast paced global leader on an interesting and complex project this would be a compelling role for you. To express your interest please reply to this role and contact: Dagmara Drozdowska; at: /+48668870261