Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom 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 successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
The clinical trial senior manager is responsible for managing single or multiple region clinical trials of moderate to high complexity or managing regional-based activities on large global trials across a range of study phases and therapeutic areasThe role is also responsible for contributing to clinical trial management department initiatives as a technical resource.
Qualifications
Coordinates internal and external clinical trial management activities of all assigned study team members involved in the study planning, start up, conduct, and closure of assigned clinical trials or study regions
Assists clinical operations program lead (copl) or global clinical operations study lead (gcosl) in the development of operational strategy and supports initial timeline development
Creates detailed study timeline with minimal support and oversight; monitors progress of timeline with cross-functional study team input:
Coordinates internal and external clinical trial management activities of all assigned study team members involved in the study planning, start up, conduct, and closure of assigned clinical trials or study regions
Assists clinical operations program lead (copl) or global clinical operations study lead (gcosl) in the development of operational strategy and supports initial timeline development
Creates detailed study timeline with minimal support and oversight; monitors progress of timeline with cross-functional study team input
Contributes to study level operational strategy, overseeing development and execution of study or regional level operational plan(s)
Helps with cross-functional vendor identification and set up and ensures appropriate ongoing oversight
Monitors approved trial budget(s) including ongoing vendor invoice reconciliation and scope of work review; works cross-functionally to initiate vendor contract changes and review revised scope of work and budgets
Supports copl or gcosl with managing investigator identification and selection for assigned clinical trials or study regions
Contributes to the development of study documentation including clinical trial protocols, study plans and clinical study reports
Identifies study risks and implements contingency plans with minimal supervision
Supports cross functional study data review where appropriate
Represents clinical trial management department as a technical resource in cross-functional initiatives or process improvement efforts (e.gSop and wi updates) as assigned by management
Mentors more junior or newly hired clinical trial management staff
May function as representative for clinical trial management on vendor-related joint operating committees
**typically requires 5 years of relevant work experience in the biopharmaceutical industry, or the equivalent combination of education and experience**
Bachelor`s degree in life sciences discipline or relevant discipline.
Strong clinical trial management track record showing clear knowledge in project management skills, cross-functional study operations and vendor management
Good understanding of gcp, cfr and ich guidelines
Demonstrates detailed understanding of clinical protocol, intended study populations and drug development
Demonstrates ability to effectively interface with key medical personnel at investigational site(s)
Strong interpersonal and communications skills to exchange complex information with others in complex situations
Ability to effectively problem solve within a cross-functional team
Demonstrates ability to effectively manage issue identification and resolution with minimal guidance
Excellent attention to detail
Ability to work successfully under pressure with tight timelines
Proficiency in microsoft office applications including outlook, excel, word, and powerpoint
Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’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 programsIn 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 harassmentAll 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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