Job Description

Description

Job Advert Posting

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.

The role:

The Clinical Trial Manager-Gen Med is responsible for the delivery of all clinical aspects of the study. The CTM oversees the clinical portion of the budget, develops monitoring plans & tools, trains CRAs, drives enrollment and study start-up activities, reviews trip reports, implements corrective and preventative action plans, liaises with the Sponsor, vendors and cross-functional teams, identifies and mitigates risks that may impact clinical delivery, and provides reporting and metrics on all clinical activities. The CTM will also participate in Sponsor, Investigator and bid defense meetings.

You will need:

You will need:

Level 1

• Bachelor's degree in a health, life sciences or other relevant field of study
• 5+ years of clinical research experience, required

• 2+ years monitoring experience, strongly preferred
• Strong knowledge of the drug development process
• Strong Knowledge and practical application of relevant regulatory requirements
• Excellent project management skills
• Excellent leadership and influencing skills
• Excellent problem solving skills
• Excellent critical thinking skills
• Proficiency with Microsoft Office and company collaboration applications
• English fluency (ability to read, write, speak), required
• Travel of up to a maximum of 10%, required

Level 2:

• Bachelor's Degree in a health, life sciences or other relevant field of study, required
• 8+ years of relevant experience, required
• 2+ years of experience in clinical trial management, strongly preferred
• 2+ years monitoring experience, strongly preferred
• Experience in managing complex or global trials, preferred
• Minimum 1-2 years of experience leading Oncology cellular therapy trials, strongly preferred.
• Experience should include oversight of clinical trials using genetically-modified or somatic cell adoptive transfer in either autologous and/or allogeneic settings where cellular product logistics management was used.
• Experience in managing all trial components (start-up to database lock), preferred
• Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives, preferred
• English fluency (ability to read, write, speak), required
• Travel of up to a maximum of 10%, required

Level 3:

• Bachelor's degree in a health, life sciences or other relevant field of study, required
• 10+ years of relevant experience, required

• 4-5+ years of experience in clinical trial management, strongly preferred
• 2+ years monitoring experience, strongly preferred
• Experience in managing complex or global trials, preferred
• Minimum 1-2 years of experience leading Oncology cellular therapy trials, strongly preferred.
• Experience should include oversight of clinical trials using genetically-modified or somatic cell adoptive transfer in either autologous and/or allogeneic settings where cellular product logistics management was used.
• Experience in managing all trial components (start-up to database lock), preferred
• Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives, preferred
• Experience in managing complex trials or global trials, preferred
• English fluency (ability to read, write, speak), required
• Travel of up to a maximum of 10%

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa stat

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.