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posted_at: 22 days agoschedule_type: Full-time
Study Site Specialist
ID...
2023-100556
Location : Location
US-Remote
Overview
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
Study Site Specialist
ID...
2023-100556
Location : Location
US-Remote
Overview
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.
Responsibilities
Under the guidance of the Director of Global Site Management & Central Services, the Study Site Specialist will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification, site level regulatory green light and site maintenance/close-outs.
Participate in development of in-house model process documents.
• For assigned sites and countries, serve as a primary site contact for end-to-end study activity.
• Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
• Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
• Oversee essential document collection, tracking & review.
• Support the collection of country and site level intelligence
• Support Ethics Committee and Regulatory Authority submissions
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank commitee approvals, etc.) required to activate or maintain sites for a study as appropriate.
Qualifications
• Bachelor's Degree in Business Administration, Finance, science or related field.
• Minimum of five years negotiating US Site contracts and budgets.
• Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
• Ability to negotiate complex contract and payment terms.
• Flexibility to assume a workload which frequently necessitates an adjustment of priorities.
• Goal oriented, self-starter with proven ability to work independently.
• Able to proactively identify issues and provide potential solutions for resolution.
• Detail oriented.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
• Proficiency with Veeva Vault and all applications of Microsoft Office.
• Good interpersonal skills.
• Comfort with ambiguity; ability to act without having the total picture.
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.
Connect With Us!
Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Show more details...
ID...
2023-100556
Location : Location
US-Remote
Overview
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.
Responsibilities
Under the guidance of the Director of Global Site Management & Central Services, the Study Site Specialist will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification, site level regulatory green light and site maintenance/close-outs.
Participate in development of in-house model process documents.
• For assigned sites and countries, serve as a primary site contact for end-to-end study activity.
• Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
• Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
• Oversee essential document collection, tracking & review.
• Support the collection of country and site level intelligence
• Support Ethics Committee and Regulatory Authority submissions
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank commitee approvals, etc.) required to activate or maintain sites for a study as appropriate.
Qualifications
• Bachelor's Degree in Business Administration, Finance, science or related field.
• Minimum of five years negotiating US Site contracts and budgets.
• Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
• Ability to negotiate complex contract and payment terms.
• Flexibility to assume a workload which frequently necessitates an adjustment of priorities.
• Goal oriented, self-starter with proven ability to work independently.
• Able to proactively identify issues and provide potential solutions for resolution.
• Detail oriented.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
• Proficiency with Veeva Vault and all applications of Microsoft Office.
• Good interpersonal skills.
• Comfort with ambiguity; ability to act without having the total picture.
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.
Connect With Us!
Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Show more details...
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