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Deputy Manager Clinical Operations
3 months ago
Job Title: Deputy Manager Clinical Operations
Experience Required: 9+ years of experience
Location: Bangalore
SUMMARY OF THE ROLE
Assist in smooth functioning of Clinical Operations department
KEY ROLES & RESPONSIBILITIES
Core responsibilities:
Review bioanalytical reports in compliance to GLP guidelines and applicable regulatory requirements
Review development and validation of Bioanalytical methods and reports using HPLC and LC-MS/MS
Review of sample processing sheets and Method SOPs
Review of Method Validation chromatograms
Communicate and co-ordinate with CROs with regard to project timelines and schedules of studies
Assist in shipment of investigational products to CRO
Monitor Bio studies for various regulatory submissions like EU, TGA, etc
Assist in preparation of BE NOC documents, Test License documents and courier declaration for investigational product shipment
Assist in documentation and SOP preparation
Assist in procurement of Working Standards and RLD Samples
Assist in preparing technical presentations
Assist in preparation of clinical and non clinical modules for dossier submissions.
Any other work assigned by the Manager from time to time
FUNCTIONAL
Up-to-date knowledge on regulatory guidelines
Knowledge of GLP and GCP
BEHAVIOURAL
Critical thinking
Interpersonal skills
Decision-making ability and crisis management
Conflict resolution
Analytical skills