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Clinical Trials Management Principal

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: September 17, 2020

Job Description:


The Principal Cli n ical Trials Ma n a ger is re sp o n sible f o r t h e pl an ni n g , i m ple m entation an d co n d uct of larg e , co m p lex cli n ical trials o r m u lti p le s m a ller st ud i es acr o ss i nd icati on s o r d e v e l op m e n t c o m p o u nd(s). T h e Principal Cli n ical Trials Ma n a g e r is expect e d t o p r ov i de lea d er s h i p wit h in t h e d e part m ent and to m ake re c o mm endati o n s with reg a r d s to t h e strategic as p ects o f Cli n ical O p erati o ns d eli v era b les.


Adv a nce those of the Senior Clinical Trials Ma n a ger to i n clu d e t h e f o ll o w i ng :

* Able t o deve l o p a n d exe c ute co m p lex st u d y plans in o n e or m o re cli n ical studies with m i ni m a l sup e rvis i on * Pro v i d es ov e rsi gh t a n d i n te g r ati o n acti v ities o f all Cli n ical O p eratio n s staff s u pp o rting assi gn e d p r o j ects * A b le t o d raft p l a n s for m u lti p le related s t u d ies, wi t h ov e rsig h t * De v e l o ps study b ud g et( s ) with ov e rsig h t * Atte n d s scie n t i fic m ee t i ng s and bu ilds relatio n s h i p s with In v esti g ators, busi n ess p ar t n ers * Partici p ates in st ud y d ata re v i ew a n d i n ter p retati o n * Partici p ates in a n d co n tr i bu tes to p u b licati o n strate g y and co n te n t * Ass u m es a lead r o le i n t h e ide n tificati o n process of In v es t i g at o rs or v end o rs a n d a ss u res p r o p er p r e qua l ification of cli n ical sites * En s u res ext e rnal and internal do c u m e n tati o n pre p ared wit h i n t h e Cli n ical O p eratio n s functi o n is c o m p leted in accord a n ce with GCP regulatory require m ents and c onsist e nt with the pro t ocol, for all as s ign e d programs/trials * May represe n t Cli n ical O p erati on s on Cli n ical De v e l op m e n t Tea m (s) * M anages team and i n divi d u al perfor m ance appropriately * M ay sup er v ise oth e r cli n ical s taff * Per f or m s o t h er d u ties as ass i g n ed


In ad d iti o n to t h e attrib u tes o f a Senior Cli n ical Trials Ma n a g e r:

* Dis p lays h ig h ly d e v e l op e d pr oj ect lea d ers h i p qu alities * Deep un d erst a nd i ng o f Cli n i c al Op e rati o ns a n d D r u g D e ve l op m ent. Ex pe r t on assi g n e d p ro t ocols * De m on strates a b ility to i n tegrate and s u mmarize m e d ical/ s c i e n tific co n ce p ts in pr o t o c o l s and o t h e r do c u m e n ts * Pr o acti v ely se e k s out a n d rec omm ends p roc e ss i m prove m ents * Pr o v e n tra c k r e co r d of antici p ating pot e n tial study is s u es an d pr e p ar i n g c o nting e ncy pla n s with m ini m al o v ers i ght * Com m unicates clearly and e ffectively with i n te r n al a n d e x t ernal key sta ke ho l ders * Routi n ely m entors an d m ay sup er v ise j u ni o r staf f . T a kes a leader s h ip r o le in on b o a rd i ng n e w per so nnel * M ay contr i bute to Cli n ical D e vel o p m ent Plans with s o m e overs i ght * C on siste n tly d e m on strates overall lea d ers h ip in Cli n ical Operati on s


* M .S. ( o r eq ui v alent e x peri e n c e) a n d 6+ y ea r s o f r elev a nt w o r k ex perien c e * B.S. ( o r eq uiv a lent e x peri e n c e ) a n d 8+ y ears of relev a nt w or k e xp e rience

Keywords: Vertex Pharmaceuticals, Boston , Clinical Trials Management Principal, Executive , Boston, Massachusetts

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