Sr. Precision Medicine Associate

Location
Tarrytown, New York, US
Posted
Jun 04, 2018
Ref
12929BR
Required Education
Other
Position Type
Full time
Position Summary

S U MM A R Y :
Wo r k s c l os e l y w it h Manager/Sr.Manager , P r e c i s i on M e d i c i ne a n d o t her k ey pe r s on n el t o i m p l e m ent and op e r a ti ona l i z e
Pr e c i s i on M ed i c i n e g oa l s w it h i n e ach o f R e g ene r on ' s c l i n i cal t r i a l s. M a n a g es ce n t r al l ab o r a t o r y and s p e c i a l t y v endo r s a nd e v a l ua t es n ew cap a b i l i t i es a i m ed at c o l l ec t i ng c l i n i c a l b i o m a r k er s a m p l es a n d m easu r e m en t s. E v a l u a t e s p e rf or m ance of
v endo r s a nd c o ll a bo r a t o r s a nd pa r t i c i p a t es i n v endor o v e r s i g ht a c ti v i t i e s . L i a i s e s w i t h i n v e s ti g a t o r s and k ey l ab pe r s onn e l
t o e n su r e s m oo t h l abo r a t or y ope r a t i ons and ti m e l y da t a t r an s f e r s. P r e s e n t s at i n ve s ti g a t o r s m ee t i n g s a nd c r e a t es t r a i n i ng m a t e ri a l s ( Lab M a n u a l , S a m p l e Col l e c t i on P r oce d u r es , p r e s en t a t i on s l i de s , e t c . ) . O v e r s e es c l i n i c al s a m p l es i n v en t o r i es and d e s t r u c ti on da t es a t a s i n g l e s a m p l e l e v e l . D e s i g ns d at a t r an s f er p l ans a nd m a i n t a i ns d a t a i n t e g r i t y . Pe rf or m s o t her du t i es a s n e ce s s ar y t o en s ur e op t i m al c l i n i c a l t r i al e xe c u ti o n.

S CO P E: N / A

JOB RE S P ON S I B I L I T I ES :

Study T e a m S u p p o r t

· Pa r t i c i p a t es i n c r o s s - f unc t i o nal s t udy t e a m s a nd su b - t e a m s .
· M a na g es a cq u i s it i on o f c li n i c a l t r i al s a m p l es d e s i g na t e d f or b i o m a r k e r s, p r e c i s i on m ed i c i ne a nd / o r e x p l o r a t o r y r e s e a r ch.
· Suppo r t s i nd i v i d u al c l i n i c a l s t udy t e a m s a nd b i o m a r k er su b - t ea m s a s r eq u i r ed f o r a l l t ec h n i c al and o p e r a t i on a l s a m p le - r e l a t ed m a tt e r s f o r a s s i g ned p r o j e c t s by l i a i s i n g w it h i n t e r nal s t a k eho l d e r s .
· A na l yz es b i o m a r k e r - and s a m p l e m ana g e m en t - r e l a t ed i s s u es a nd u s es j u d g m ent t o e s c a l a t e i s s u es t o t he app r o p r i a t e t eam m e m be r s .
O per a t i onal Su p port o f B i o m a rker and E x plo r a t o r y A naly s i s
· A s si s t s P re c i s i on M e d i c i ne Sc i e n t i s t s by a s s e s s i ng v endo r s, f o r ec a s t i ng t he b i o m a r k er s a m p l e o p e r a t i on a l co s t s, and r e v i ewing i n v o i c e s.
· P r o v i des i np u t on b i o m a r k er s e c t i ons i n c l i n i c al t r i a l - r e l a t ed ( su c h as p r o t oc o l s a nd con s e n t s ) a n d o t h er supp or ti ng docu m en t s un d er sup e r v i s i on of A s so c i a t e D i r e c t o r .
Se l e c t i on o f C en t r al L ab o ra t o r y and S p e c i a lt y V e n dors
· Pr e p a r es R F P s, r e v i ews a n d a s s e s s b i ds and S O W s .
· E v a l ua t e s e m e r g i ng t echn o l o g i es and v end o r s t o c o ns i d er f o r f u t u r e p r o g r a m s .
· C oo r d i na t es c apa b i l i t i e s p r e s e n t a t i ons by no v el v endo r s and p e rf o r m s Func t i on a l A r ea A s s e s s m en t s .
· A tt en d s c o n f e r e n ces t o i de n t i f y new m e t hodo l o g i es and t ec h no l o g i e s .
C en t r a l L abor a t ory and S pec i a lt y V endo r s M an a g e m ent
· M a na g es r e l a t i on s h i p s w i t h cen t r a l l abo r a t o r y and s p e c i a l t y v endo r s i n c l ud i ng de f i n i ng con t r a c t s and v endor o v e r s i g ht m ana g e m en t , w i t h t he supp o r t of t he app r o p r i a t e s t udy t eam m e m be r s .
· T a k es r e s p on s i b i l i t y f or c o o r d i n a t i on o f e v en t s, l i a i s on s wi t h v endo r s, and c o m m u n i c a t i on wi t h a cade m i c co l l ab o r a t o r s .
· Pa r t i c i p a t es i n o v e r s i g ht a c t i v it i es wi t h v end o r s a n d s u ppo r t s a u d i t s a s r e qu i r e d .
D a t a M a i n t enance and M anage m ent
· Suppo r t s i n f o r m a ti on exc ha n g e and m a i n t a i n d a t a i n t e g r i t y .
· Pro v i des g u i d ance and tr a i n i ng t o c li n i c a l s i t e s , co l l ab o r a t o r s and v end o r s t o en a b l e t r an s f er of b i o m a r k er and exp l o r a t o r y d a ta .

· Suppo r t s s a m p l e and d a t a r econ c i l i a ti o n a c ti v i ti e s .
· E v a l ua t e s d a t a i n t e g rit y and co m m u n i ca t e s a ny po t en ti al i s s u es t o P r ec i s i o n M e d i c i ne S c i en t i s t s, D a t a
M a na g e m ent and o t h e r i n t e r na l / e x t e r n a l s t a k eho l de r s .
C o m p l i ance M a i n t enance i n C o l l e c t i on a n d P r o ce ss i ng o f H u m an B i osp e c i m e n
· Pro v i des g u i d ance t o c l i n i c al s t udy t ea m s a nd c l i n i c a l s i t e s r e g a r d i ng co l l e c tio n a nd s t o r a g e of b i o sp e c i m en acqu i r ed i n t he cou r se o f c l i n i c a l t r i a l s or o t h er hu m an s a m p l e acq u i s i t i on p r o j e c t s .
· Wo r k s w i t h I C F S pec i a l i s t and P r ec i s i o n M e d i c i ne Sc i en t i st t o en s u r e c o m p li an c e w it h I C F pe r m i s si o n s .
P r o ce s s Dev e l o p m e n t and I m p r ov e m ent
· Wo r k s w i t h i n a m a tr i x en v i r on m en t , c o l l abo r a t i ng w it h i n t e r n al a nd e x t e r n a l c u s t o m e r s a s n e e ded t o i m p r o v e ex i s t i ng p r oc e s s i ng and i de n t i f y a need f or de v e l op m ent of new p r oc e s s e s

J O B RE Q U IR E ME N T S

· Wo r k i ng k no w l ed g e of t h e c l i n i c al d r ug de v e l op m ent p r oc e ss
· Ef f e c t i v e p r o b l em so l v i ng s k ill s
· Exce l l e n t w r i t t en and v e r b a l co m m un i ca t i on and p r e se n t a ti on s k i l l s i n s m a l l and l a r g e g r oup s e t t i n g s
· Wo r k i ng k no w l ed g e of I C H / GC P and r e g u l a t o r y g u i de l i ne s / d i r e c t i v es
· Wo r k i ng k no w l ed g e of C L I A / CA P r e g u l a ti o n s a nd G LP g u i de l i nes
· T h e r a p eu t i c a r e a k no w l ed g e
· Sc i e n ce b ac kg r ound and w o r k i ng k no w l ed g e of a wi d e a r r ay of b i o l o g i c al a s s a y s i n c l ud i ng p r o t e o m i c s , c e ll u l ar a s s a y s, g eno m i c s , e t c.
· U nde r s t an d i ng of b i o e t h i cs of hu m an b i o sp e c i m en co ll ec t i on a nd r e s e a r ch
· A b i l it y t o e f f e c ti v el y m u lti - t a s k and p ri o r it i z e
· A b i l it y t o w o r k i n a m a tr i x en v ir on m ent
· Fin a n c i a l bud g e t i ng and f o r eca s ti ng s k i l l s
· Pr o j e ct m ana g e m en t/ o r g an i z a ti on a l s k i l l s
· I n t e r pe r s o nal s k i l l s
· C r os s - f unc t i on a l a nd c r os s - cu l t u r a l a w a r e n e s s
· Exce l l e n t co m pu t e r s k i l l s i nc l u d i n g M i c r o so f t s u i t e a n d M i c r o so f t A c c e s s

ED U C A TION

· B .S de g r ee – M a j o r / M i nor ( B i o l o gy , B i oche m i s tr y or equ i v a l e n t )
· M.S de g r ee i s a p l us

EX P ERIENCE

· 6 - 8 y ea r s ph a r m aceu t i c a l i ndus t r y expe r i e n c e .

Requisition Number: 12929BR