Project Support Specialist

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