Ref #: 25895

Employment type: Permanent - Full-Time

Location: Poland

Posted: 03-Apr-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.

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.


Overview:
The Global Study Associate Manager (GSAM) will lead and coordinate activities that ensure quality, consistency, and integration of global study progress. You will work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development and different therapy areas.


Responsibilities:
Monitor study conduct and progress, proactively identifying to and resolving with the Global Study Leader, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives
Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
Lead the preparation of study documents as delegated by Global Study Leader( e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card etc)
Support the study delivery team and Clinical Advice and Assurance (CA&A) in the development of and implementation of audits and regulatory inspections
Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities
Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents
Provide input and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan)
Contribute to review of new/amended/unique project Clinical Information Standards (CIS) Standards Repository Components
Ensure timely entry and/or update appropriate information into company's tracking and communication tools (e.g. IMPACT, ISSIS and Clinical Partners Portal)
Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate
Contribute to the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
Contribute to steering committees, submission assembly teams, regulatory defence teams, and Advisory Boards as necessary

Requirements:
Experience working on clinical studies as a Project Coordinator/Associate/Specialist Global CTA or InHouse/Remote CRA across different phases of drug development
Excellent knowledge of spoken and written English
Vendor management experience
University degree in science preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to Study delivery operational activities


How to apply?
This is an exceptional opportunity within a global organisation who offers rewarding careers. If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, please contact Dariusz Sternlicht, Recruitment Consultant at DOCS and email your up-to-date CV to: dariusz.sternlicht@docsglobal.com


Benefits of working in ICON
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.


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