Project Support Specialist

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Re spo n sible f or handling t h e me trics in v a rio u s s y st e ms. Co ordin a t e s a n d s u pports a ss i gned PSS st a f f an d w or k s c losely w i t h f u n c tio n a l l ea d s to e n s u re op t i ma l op e r a tio n a l p e r f or m a nc e .

Helps st u d y tea ms to m a i n t a in a u dit r ea diness b y brin g i n g f or wa rd i nn o v a ti v e id ea s a n d inquisitive n e w wa y s of w or k i n g. S u pports c r ea tio n , i m pl e m e n t a tion a n d ch a n ge ma n a g e m e n t f or d e p a r t m e n t a l a n d cros s - f u n c tio n a l pr o c e s s i m prov e m e n ts/ e nh an c e m e n ts i n iti a ti v e s.

S u pports w i t h risk a ssess m e n t a n d a n a l y s i s to a v oid p ossible d e v i a ti o n s a n d n o n c om p li an c e w ith e st a bl i s h e d p r o c e sses.

Pro v id e s e n d t o e n d o v e rsi g h t a n d f o llow u p on s t u dy l e v e l a c ti v iti e s a i m i n g t o mi n i m ize a n y i n c o n sist e nc i e s in te r m s o f c o mpli a nc e w i th s y st e ms, interpersonal/ c u stom e rs p r o c e sses a n d p r o c e d u r e s a c cu r a t e ly a ppli e d a t a ll l e v e ls.

Provide r e c o n c ili a tio n , o v e rsight a n d f ollow u p on s y s t e ms a n d t r a i n i n gs f or v a rious F u nc ti o n a l D e p a r t m e n ts. D ir e c t c o m m un i c a tion w ith F u nc ti o n a l L ea ds t o f ollow u p a n d i n c r ea se t r a i n i n g compli a nc e > 9 9 % o n s t u dy l e v e l.

A t t e n ds ( if r e quire d ) e xt e r na l mee ti n gs & te l e c o n f e r en c e s w ith c l i e n ts. S u pports w ith pr e p a r a tion of pr e se n t a tio n s i n c l u d i n g i n f or ma ti o n a bout K e y P e r f or ma nc e I n dicato r s, m e tr i c s, s t a t u s a n d possi b le c h a ll e n g e s w ith s y st e m s

Act as oversight on eTMF-specific activities, with a preference for team members with current experience as lead on eTMF activities.

Possess a high level of experience in all eTMF-oriented activities, including filing, file review, running reports to investigate gaps, and preparing eTMF for audits. Have experience with eTMF and one or more client eTMF platforms.

Qualifi c a t i o ns

E du c a tion a n d E xp e ri e nc e : B a ch e lor ' s d e gr e e or e qu i v a l e n t a n d r e l e v a n t f or ma l a c a d e mic / v o c a ti o n a l quali f i c a tion Previous experience that provides the knowledge, skills, and abilities to perform the job (more than 5 years).

Extensive expert level Lead PSC experience. Experience with clarity including activities like Team tab review, ‘Under Forecast Value change’ column review, reconciliation of clarity to analyse variance with the budget etc.. Experience with Client Coordination Preparing client compliance reports and creating slides for CRA meetings. Hands on experience with Audit preparation Assisting the Global Project Leader with preparation of Study Plans