ICON plc is a world-leading healthcare intelligence and clinical research organization.
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing: P l a n n i n g , m a n a gement, and o v e r s i g h t o f c li n i c a l s t ud y e x e c u t i o n i n a cc o r d a n c e w i t h t h e g l o b a l p r o g r a m s t r a t e gy, t h r o u g h l e a d e r s h i p o f t h e c r o ss-functional L o c a l S t ud y T e a m ( L ST).
S u p po r t s c oun t r y-l e v e l o p e r a t i o n al p l a n n i n g a n d a c c ou n t a b l e fo r s i t e s e l e c t i o n w i t h i n a ss i g n e d c ou n t r y / - i e s .
Contributes a n d d e v e l o ps t o p r o g r a m /study-specific m a t e r i als - e .
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, m on i t o r i n g p l a n , s t u d y s p e c i f i c t r a i n i n g do c u m e n t s. S u p po r ts a n d c on t r i bu t es t o C l i n i c al S t u d y T e a m s ( CSTs) / T r i a l M a n a gement T e a m s ( T M Ts ) a s a pp l i c a b l e , a genda d r i v e n , p r e s e n t a t m ee t i n g s. Communicates c oun t r y s t a t u s (i n c l u d i n g t i m e l i n e s a n d d e l i v e r a b l e s ) t o k e y s t a k e h o l d e r s ( e .
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, G loba l C l i n i c a l M anagers [GCM], P r o g r a m M a n a gers, C S T o r T M T , D e v e l o p m e n t O p e r a t i o n s Man a g e r [ DOM] e t c ) w i t h ov e r s i g h t a s r e qu i r e d a n d e n s u r e s upd a t e s t o r e l e v a n t s y s t e m s .
A cc oun t a b l e fo r s i t e - l e v e l g o a l s e tt i n g a n d s t u d y-s p ec i f i c d e l iv e r a b l e s f o r c l i n i c a l s i t e s w i t h i n t h e i r c ou n t r y / -i e s .
Contributes t o , d e l iv e r and/or l e ad CRA, I n v e s t i g a t o r and S t u d y Coordinator t r a i nin g .
P r ovides o v e r s i g h t a n d monitoring o f a pp l i c a b l e v e n do r a c t iv i t i e s e .
g., l a b o r a t o r i e s a n d e q u i p m e n t p r ov i s i o n i n g .
E n g ages w i t h l o c a l c l u s t e r t e a m a n d l o c a l fun c t i o n s f r om a s t u d y p e r s p e c t i v e ( e .
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, L o c a l M e d i c al A ff airs team, D O M ) P r o vi d e s c o u n t r y l e v e l i n p u t i n t o t h e C oun t r y O p e r a t i o n al P l a n ( COP) a n d p a r t n e r w i t h t h e DFM t h r ou g h f e a si b i li ty a n d w i t h t h e G C M s t o e n s u r e l o c a l d e l i v e r y o f t h e s t u d y .
R e s pon s i b l e fo r a pp r o v a l o f B a s e li n e and R e v i s e d E n r o l m e n t P l a n s ( C oun t r y L e v e l ) Contributes to the s tudy-level f orecast f or i nvestigational product, s upport s tudy l evel accountability and r econciliation across a ss i gned c ountries, m anagement of E LE ( enrolment l o ng-range estimates) process.
Monitors the execution of the cl i nical s tudy against timelines, d eliverables, a nd budget f or that c ountry.
T r anslates global s tart u p r equirements i nto l ocal c ountry targets Monitors c ountry enrolment a nd r etention and act on deviations f r om plan.
Identify barriers to enrolment and s upport r ecruitment and r etention s trategic s olutions.
Monitors and acts upon d ata f l o w m etrics - r eview, trend i dentification a nd an alysis, w i t h targeted f ollow up where appropriate.
Monitors and r e v i e w s c ountry and s tudy trends.
Reviews Monitoring Vi s i t R eports.
Identifies and f acilitates r esolution of cr oss-functional s tudy-specific i ss ues.
P r ovides u pdates r egarding the s t udy b udget and obtains approval f or budget deviations f or c l i nical s i tes ( outside of r ange).
E sc alates any i ss ues r elated to delivery, timelines, or b udget to G C Ms ( or T MT l e ad i f appropriate).
E sc alates CRA performance i ss ues to applicable C l i nical T r i al Ov ersight Manager.
Conducts on-site q uality vis i ts with CRAs w here/when appropriate and s upports the m aintenance of s i te r e l ationships.
You Are: Doctorate degree OR Master's degree & 3 years of directly related experience OR Bachelor's degree & 5 years of directly related experience OR Associate's degree & 10 years of directly related experience Minimum 2-3 years' experience of leading local/regional trials What ICON can offer you: Our success depends on the quality of our people.
That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits.
Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
We're proud of our diverse workforce and the work we've done to become a more inclusive organization.
We're dedicated to providing an inclusive and accessible environment for all candidates.
ICON 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 through this form .
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