Senior Manager Clinical Operations

3 weeks ago


Bengaluru, Karnataka, India LYRUS LIFE SCIENCES PVT LTD Full time

Job Title: Deputy Manager Clinical Operations

Job Summary: We are seeking an experienced Deputy Manager Clinical Operations to join our team at Lyraus Life Sciences PVT LTD. This role will assist in the smooth functioning of the Clinical Operations department, ensuring compliance with regulatory guidelines and applicable requirements.

Key Responsibilities:

• ⁠Review bioanalytical reports in compliance with 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.

Requirements:

• ⁠Up-to-date knowledge on regulatory guidelines.

• ⁠Knowledge of GLP and GCP.

• ⁠Critical thinking.

• ⁠Interpersonal skills.

• ⁠Decision-making ability and crisis management.

• ⁠Conflict resolution.

• ⁠Analytical skills.



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