Sr. Precision Medicine Associate

Location
Tarrytown, New York, US
Posted
Jul 13, 2018
Ref
12929BR
Required Education
Other
Position Type
Full time
Position Summary

S UMMARY:
Work s cl os el y wit h Manager/Sr.Manager , P r e ci s i on M e di c i ne a n d o t her k ey pe rs on n el t o im p l e m ent and op er a ti ona liz e
Preci s i on M ed i c in e g oa l s withi n e ach o f R e g ene r on ' s cli n i cal trial s. M an a g es ce ntr al l ab or a t o r y and sp e ci a lt y v endo r s a nd e v a l ua t es n ew cap a b iliti es aim ed at c oll ec ti ng c li n i c a l bi o m a rk er s am p l es a n d m easu r e m en t s. E v a lu a te s p erform ance of
v endor s a nd c olla bo r a tor s a nd pa rti c ip a t es i n v endor o v e rsig ht a ctivities . L i a i s e s wit h i n v e stig a tor s and k ey l ab pe rs onn e l
t o en su r e sm oo t h l abo r a tor y ope r a ti ons and tim e l y da t a tr an sf e r s. P r e se n t s at i n ve s tig a t o r s m ee ti n g s a nd c re a t es trai n i ng m a t e rial s ( Lab M a n u a l , Sam p l e Col l e cti on P r oce d u res , p r e s en t a ti on s li de s , e tc . ) . Ov e r s e es cli n ic al s am p l es i n v en t o ri es and d e s tr u cti on da t es a t a s i n gl e s am p l e l e v e l . D e sig ns d at a tr an sf er p l ans a nd m a i n tai ns d a t a int e grity . Pe rform s o t her du ti es a s n e ce s s ar y t o en sur e op tim al c li n i c a l tri al e xe c u tio n.

S COPE: N / A

JOB RESPONSIBILITIES:

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

• Pa rtici p at es i n c r o ss-f unc tio nal st udy te a m s a nd su b-t e ams .
• M a na g es a cq ui s iti on o f clini c a l tri al s am p l es d e s ig na te d f or b i o m a rk e r s, precisi on m ed i c i ne a nd /o r e x p lorat o r y r e se a r ch.
• Suppo rt s i nd ivi d u al c li n i c a l s t udy te a m s a nd b i o m a rk er su b-t ea m s a s r eq uir ed fo r al l t ec h n ic al and o p e r a ti on a l s am p le-r e l a t ed m a tt e r s fo r a s s ig ned p roj e ct s by liai s in g wit h int e r nal s t a k eho l d ers .
• A na lyz es b i o m a rk e r - and s a m p l e m ana gem en t-r e l a t ed i s su es a nd u s es j u dgm ent t o e s c alat e i s su es t o t he app r o pri a t e t eam mem be rs .
O perati onal Su p port o f Bi o ma rker and Ex plo r a t o r y A naly si s
• A s sist s Precisi on M edi c i ne Sc i e nti s t s by a s s e s si ng v endo r s, f o r ec a s ti ng t he bi o m a rk er s am p l e o p e rati on a l co st s, and r e vi ewing i n v o i c e s.
• P r o vi des i np u t on bi o m a rk er s ecti ons i n cli n ic al trial-r e l a t ed ( su c h as pr o t oc ol s a nd con se n ts ) a n d o th er supp orti ng docu m en t s un d er sup ervi s i on of As so ci a t e D ir e ct o r .
Sel e cti on o f C en tr al L ab o ra t o r y and S pe c ialt y V e n dors
• Pr e p ar es R F P s, r e vi ews a n d a ss e s s bi ds and S O W s .
• E v a l ua te s e m e rgi ng t echn ol o gi es and v end or s t o c o ns id er fo r f u tur e pr o gr a ms .
• C oo r d i na t es c apa bilitie s p re s e n t a ti ons by no v el v endo r s and p erform s Func ti on a l Ar ea As s es s m en ts .
• Att en d s co n fer e n ces t o i de ntif y new m e t hodo l o gi es and t ec h no l o gies .
C ent r a l L abor at ory and S pec ialt y V endo r s M an a g em ent
• M a na g es r e l a ti on s h ip s w it h cen tra l l abo r a tor y and sp e ci a lt y v endo r s i n cl ud i ng de fi n i ng con tr a ct s and v endor o v e r s ig ht m ana g e m en t , wit h t he supp or t of t he app ro p ri a t e st udy t eam mem be rs .
• T a k es r e sp on si b ilit y f or c o o r d in a ti on o f e v en t s, liai s on s wi t h v endo r s, and c o mmu n i c ati on wit h a cade mi c co ll ab or a t o rs .
• Pa rtici p at es i n o v e r s ig ht a c tiviti es wit h v end or s an d s u ppo rt s au d it s a s re qu ir e d .
D at a M ai n t enance and M anage m ent
• Suppo rt s i n form a ti on exc ha n g e and m a intai n d at a i n t e grity .
• Pro vi des g u id ance and train i ng t o clini c a l sit e s , co ll ab or a tor s and v end or s t o en a b l e tr an sf er of bi o m a rk er and exp lorat o r y d ata .

• Suppo rt s s a m p l e and d a t a r econ ciliatio n a ctivities .
• E v a l ua te s d at a i n t e grit y and co mmu n i ca te s a ny po t en ti al i s su es t o P r ec i s io n M e d i c i ne S c i en tist s, D at a
Ma na g e m ent and ot h e r i n ter na l/ e xter n a l st a k eho l de rs .
C om p li ance M ai n t enance i n C o ll e cti on a n d P r o ce ssi ng o f Hum an Bi osp e c ime n
• Pro vi des g u id ance t o c li n ic al st udy t ea m s a nd c li n i c a l s ite s r e g a rdi ng co ll e ctio n a nd s tor a g e of b io sp ecim en acqu ir ed i n t he cou r se o f cli n i c a l tri a l s or o th er hu m an s am p l e acq uisiti on proj e cts .
• Wo rk s w it h IC F S pec i a lis t and P r ec i s io n M e d ici ne Sc i en ti st t o en sur e c o m p li an c e wit h IC F pe rmi s si o ns .
P ro ce s s Dev el o pm e n t and I m p r ov em ent
• Works within a matrix environment, collaborating with internal and external customers as needed to improve existing processing and identify a need for development of new processes

JO B REQU IR E ME NT S

• Wo rki ng k no wl ed g e of th e c li n ic al dr ug de v e l op m ent p r oc e ss
• Ef fe c tiv e p r o bl em so lvi ng s kill s
• Exce ll e n t writt en and v e r b a l co mm un i ca ti on and pr e se n tati on s kill s i n s m a l l and l a rg e gr oup s etti n g s
• Wo rki ng k no wl ed g e of ICH/GC P and r e g u l a tor y g u i de li ne s/ d ir e ctiv es
• Wo rki ng k no wl ed g e of C L IA/CA P r eg u lati o n s a nd G LP g u i de li nes
• T h er a p eu ti c a re a k no wl ed g e
• Sc i e n ce b ac kgr ound and w o rki ng k no wl ed g e of a wi d e a rr ay of bi o l o gic al a ss a y s i n cl ud i ng p r o te o mi c s , c ellul ar a s s ay s, g eno mi c s , et c.
• U nde rst an di ng of bi o et h i cs of hu m an b i o sp ecim en co ll ec ti on a nd r e se a r ch
• A b ilit y t o eff e ctivel y m u lti-t a s k and prioritiz e
• A b ilit y t o wor k i n a m a tri x en vir on m ent
• Fin a n cia l bud g e ti ng and f o r eca sti ng s kill s
• Pr oje ct m ana g e m en t/ o rg an iz a ti on a l s kill s
• I n t e r pe r s o nal s kill s
• Cr os s-f unc ti on a l a nd cr os s- cu lt u ra l a w a r e n e s s
• Exce ll e n t co m pu te r s kill s i nc l u din g M i c ro so f t s uit e a n d M i c ro so f t A c c e s s

EDUCATION

• B .S de gr ee - M aj o r / Mi nor (Biol o gy , Bi oche mi s tr y or equ iv a le n t )
• M.S degr ee i s a p l us

EXPERIENCE

• 6 - 8 y ea r s ph arm aceu ti c a l i ndus tr y expe r ie n c e .