Clinical Trial Manager

As a CTM you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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: Organised, creative and confident in taking independent action.
To ensure success within this role, the following are required: A proven track record within study management An ability to combine creativity, leadership and experience to empower a team to succeed Prior experience of budget forecasting, feasibility, study start up, on-site monitoring and site management Confidence in your decision-making abilities A working knowledge of a broad range of therapeutic areas Degree in a health or science related discipline Fluency in English 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 organisation.
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 the form below.
https://careers.iconplc.com/reasonable-accommodations 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.