Manager, Study Start Up
- United States
- Study Start Up
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
As a Manager, Study Start Up you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Working directly with Investigative Sites, this role will independently manage and perform activities at a site level associated with study start-up including regulatory document collection, preparation of ethics submission documents, informed consent review and essential document package review.
- Must have an in-depth understanding of study start-up activities and associated regulatory requirements.
You are:
- Bachelor’s degree with a major in a related field (or equivalent experience) and at least 5 years of experience in study start-up In-depth knowledge of start-up processes and procedures
- Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
- Experience with investigative site start-up documents
- Good understanding of clinical trial execution
Key Competencies Required
- Ability to work under pressure to meet deadlines
- Self-motivated and ability to work well independently and in a team environment
- Ability to effectively manage multiple priorities
- Excellent verbal and written communication
- Excellent project management skills
- Excellent collaboration skills
- Meticulous attention to detail and process-oriented
In addition to experience listed above:
- Minimum of 8 years prior experience within a clinical role – for example Clinical Operations, Study Start Up, Clinical Team Manager - Highly preferred
- Undergraduate degree (or its international equivalent - Or equivalent related industry experience) in clinical, science or health-related field from an accredited institution
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
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Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
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07/20/2023
Summary
Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic
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BlogsPublish date
02/28/2023
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John Bailey, one of ICON's Veteran Leadership Transition Program Alumni shares his path from serving in the armed forces to joining the clinical research industry. ICON's Veteran Leadership Transit
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Who we are
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