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

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