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