Clinical Study Manager, European studies (#45695055) 

Reading, South East, United Kingdom

Job 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.

As a Clinical Trial Manager you will look after European clinical studies and be responsible for leading the regional matrix team to ensure delivery of country and site level study activities in alignment with the global study project plan. You will need experience in leading/managing pan-European studies.

The role:
Identifying and resolving issues at a regional level Collaborating with Global Clinical Trial Manager(s) 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 Ensuring regional, country and site vendor set-up, conduct and quality e.g. laboratories and equipment provisioning 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 Supporting audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate Executing regulatory agency inspection readiness activities (e.g. TMF review, story board generation) within region Supporting and contributing to Clinical Study Team(s) Ensuring relevant systems are updated to enable accurate reporting of study progress and milestone deliverables Ensuring key stakeholders are kept informed of study progress e.g. Global Clinical Trial Managers, etc. Contributing to development of study-specific materials e.g. monitoring plan, study specific training documents Participation in cross-functional task forces / process improvement groups

Key requirements:
Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines 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

What is required
BA/BS/BSc in the sciences or RN Ideally, a minimum of 6 / 7 years work experience in life sciences or medically related field, with ideally at least 4 years clinical research experience obtained working on clinical trials either within a biotech, pharmaceutical or CRO company Proven track-record of European clinical studies (commercial/industry-sponsored studies) Experience in working with external clinical research vendors (CROs, central labs, imaging vendors, etc.) Full-time availability Full and valid UK working eligibility

What is offered
Permanent and full-time contract of employment seconded to the client; Office-based in the Berkshire or Hampshire area (England) 3 days per week with 2 days homeworking flexibility; Fully homebased can also be considered Competitive salary depending on level of skills and experience; Company benefits: 25 days annual leave plus UK bank holidays, car allowance, pension and healthcare.

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 have clinical study experience across multiple countries with the pharma/CRO industry, please send your CV* in Word format to [email protected] or ring +33 964 25 67 65 for more details.

*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

Company Details

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Job Location
South East
United Kingdom