Senior Clinical Data Manager at Siro Clinpharm

We're actively looking for an experienced Senior Clinical Data Manager who is available to join immediately or within a short notice period.Key Responsibilities:Lead end-to-end Clinical Data Management activities for global clinical trials.Ensure submission readiness and TMF archival/inspection readiness.Manage study timelines, deliverables, budgets, and vendor oversight.Collaborate with Clinical Operations, Biostatistics, Statistical Programming, and other cross-functional teams.Ensure data quality, timely database lock, and compliance with FDA, ICH-GCP, and GxP requirements.Drive continuous improvement initiatives and support implementation of data management best practices.Required Skills:6+ years of Clinical Data Management experience.Hands-on experience with Veeva Vault EDC, Medidata Rave, Oracle InForm, Oracle Clinical, or similar EDC systems.Strong knowledge of CDISC/SDTM, MedDRA, and WHO Drug coding.Experience with clinical trial documentation (Protocols, CRFs, SAPs, CSRs).Knowledge of FDA, ICH-GCP, and regulatory requirements.NDA/CTD submission experience is an added advantage.Immediate joiners are highly preferred.Please send your resume to sachi.dubey@siroclinpharm.com

Senior Clinical Data Manager

Emma

Responsibilities

Skills wanted:

Language(s) required:

Sachi Dubey

Sachi Dubey

About Siro Clinpharm:

www.siroclinpharm.com/

Admin access needed