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Senior Clinical Study Manager (phase 1)

Employer
ICON - EMEA
Location
Hungary
Salary
Competitive
Start date
23 Sep 2022
Closing date
29 Sep 2022

View more

Discipline
Clinical Research, Clinical Development
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

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.

Clinical Study Manager (phase 1):

• Provides clinical trial management for phase 1 studies, performs quality checks, protocol and document development, and executes study delivery plans aligned with program goals and timelines.

• Participates in the assessment, preparation and implementation of studies for the clinic to ensure a timely and high-quality study output.
• Reviews and assesses the research protocol, clinic budget, case report forms, informed consent forms and study volunteer information.
• Conducts feasibility analysis. Reviews availability and workload for study volunteers, practicability and required personnel. Creates risk analysis and contingency plans. Plans and coordinates in- and outpatient visits.
• Serves as liaison between all clinic groups and the applicable clinic management. Communicates any changes in scope and/or cost and escalates issues and/or major deviations. May serve as clinic contact for the study sponsor.
• Prepares and reviews source and clinic documents, including study specific instructions, briefing, information cards, etc. May ensure submission of documents to the Institutional Review Board (IRB).
• Ensures proper sampling, collection and transmission of research data samples.
• Monitors the study timelines and output by clinic staff according to protocol and internal procedures.

Qualifications:

• Good knowledge of GCP/ICH guidelines

• Experience with phase 1 studies is preferable but not a must

• Good knowledge of internal and external regulations, standard operating procedures and work instructions

• Good knowledge of pharmacokinetics and pharmacodynamics
• Strong written and oral communication skills
• Good ability to consult with project team members and give directions and instructions to clinic staff and management

• Bachelor's degree

• Several years of relevant experience on CRA/ Regulatory/ CTM roles

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 through the form below.

Are you a current ICON Employee? Please click here to apply: link

Company

We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

Find Us
Mini-site
ICON - EMEA
Telephone
01628 496300
Location
3rd Floor
Marlow International
Marlow
Buckinghamshire
SL7 1YL
GB
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