About the role:

Senior Clinical Data Associate -responsible for day-to-day data processing operations for data management projects, including CRF (or other study data document) tracking, entry, and filing. Provides administrative and project management support to CDMs for data management projects as required, including creation and maintenance of project files. Support and mentor junior staff members. Conducts all responsible activities according to ICH-GCP and GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.

Minimum Qualifications & Experience:

- Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered.

- At least 2-4 years' experience working in a Clinical Data Associate (or equivalent) role in a Pharmaceutical industry or related role.

Responsibilities:

M e mber o f the proj e c t t e a m r e p o rting to the B i o met r ics P roj ec t M a n a g e r on proj ec ts, the S e nior Cl i nic a l D a ta As s o c iate is r e spons i ble for indep e nd e nt l y providi n g acc ur a t e d a ta ac quis i t i on, d a ta v a l i d a t i on, re c on c i l iation a nd mento r ing the jun i or sta f f to the c l i nic a l stud i e s a nd sh a ll e nsure q u a l i t y stand a rds p e r SO P s a nd I CH - GC P .

- P e r f orm c ompr e h e nsive d a ta m a n a g e ment tasks including d a ta r e v i e w, qu e r y man a g e ment, e x te r n a l d a ta rec o n c i l iation.

- T rac ki n g of CRF p a g e s (or other study data documents ) received and entered ; tr ac ki n g of d a ta q u e ri e s r e ce i v e d ; pro a c t i ve m e tric r e porti n g of CRF p a g e s (or other stu d y d a ta d o c uments) re ce ived a nd e nte r e d to stu d y t e a m m e mbe r s

- P r e p a re a nd v a l i d a te d a t a b a se sp ec if i ca t i on a nd e d it c h ec ks spe c if i ca t i on p r o ce dur e s





- A cc u r a te a nd t i me l y filing of CR F s (or other study d a ta do c uments), D C F s, or other

- DM re lat e d d o c uments ( e g . D ata M a n a g e ment P l a n, S e l f - Evid e nt C or r e c t i ons).

- A cc u r a te a nd t i me l y a r c h iv i ng of stu d y DM F , C R F F i l e s, a nd D a ta Qu e r y M a ster F i l e.

- P e r f orm us e r a c ce pta n c e testing o f D a ta Ent r y S c r e e n and c onsisten c e c h ec ks o f

- Cl i nic a l S tu d y D a tab a s e s a s r e quir e d.

- M e ntor jun i or CDA sta f f a s r e quir e d.

- R e pr e s e nt D a ta M a n a g e ment T ea m on a ll CDA r e lat e d matt e rs, both inte r n a l l y a nd e x te r n a l l y e . g . I nv e st i ga t or m ee t i n g s, a udi t s e tc.

- S uppo r t CDM w i t h C D M role ac t i vi t ies w h e r e a ppro p ri a te.

- C a n ac t as int e r n a l DM L ea d on studies, re p o rt i ng to C DM/ S CDM on a st u d y le v e l.

- L iaison with e x te r n a l se r vice pro v ide r s on D a ta M a n a g e ment p r o j ec ts as a p prop r iate.

- P ro a c t i ve p a rti c i p a t i on in proj ec t m ee t i n g s a s r e q u e sted b y CDM.

- P r e p a re a g e n d a / m inu t e w riting for d a t a m a n a g e ment te a m m ee t i n g s ; be t h e le a d/f a c i l i t a tor on C DA - r e la t e d top i c s/d i s c uss i on including pr e p a r ing top i c pr e s e ntations, and b e i n g CDA subj ec t m a t t e r e x p e rt.

- P rovide g e n e r a l a dm i n a nd proj ec t man a g e ment support to D a ta M a n a g e ment T ea m a s r e quir e d.





- Adh e r e n c e to c ompa n y Qu a l i t y P ol ic y a nd proc e dur e s a s a ppl i ca ble to c a r r y i n g out job r e spons i bi l i t ies; a w a r e n e ss of other stu d y t e a m role pro c e dur e s a nd how th e y in t e r a c t / a f f e c t C DA role.

- P ro ac t i ve contribution to company pr o ce ss improvement initiatives as r e quir e d; id e nt if y opportunities for improvements with the DM Team ; le a d CDA r e la t e d pro c e ss i mprov e ments.

- Und e rst a nd t h e r e spo n sib i l i t i e s of Novot ec h a s a s e rv i c e p rovi d e r in the ph a rm a c e ut i ca l indust r y a nd e nsure a ll c om m unic a t i ons with e x te r n a l p a rti e s pr e s e nt a posit i ve pro fe ss i on a l i mage of the c om p a n y.

- P a rti c ipation i n indust r y fo r a ( c onfer e n c e s, pro f e s sional a ssoci a t i ons e tc) a s a me a ns

- of p r of e ss i on a l d e v e lop m e nt as we ll a s promot i on of N ovote c h’s im a ge in i ndust r y .

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work workplace where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working in clinical research and biotech, including people who identify with LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to responding to every application. We look forward to talking to you about working at Novotech.

📌 Senior Clinical Data Associate (India)
🏢 Novotech
📍 India