Manager- Clinical Research

Job Description:

• Review of clinical trial and bioavailability and bioequivalence clinical study protocols, Literature search, relevant study documents such as CRF, ICF etc and Clinical study report (eCTD) including appendices.
• Review of documents such as Clinical overview and Non-Clinical Overview, bioequivalence study check-lists, addendum to clinical overviews etc.
• Thorough knowledge of most of the regulatory guidelines – USFDA,EMA, DCGI, ICH GCP etc.,
• Review of bioanalytical method validation and bioanalytical reports.
• Co-ordinate with the internal team for getting the documents for DCGI BE NOC application.
• IMP shipment to CROs after obtaining the EC and or BE NOC approval before the study initiation.
• Preparations and review of scientific justifications for regulatory advice, Bio-waiver justifications and scientific rationales.
• Preparation and review of Pack inserts and Patient information leaflet for various regulatory authorities.
• Feasibility assessment of study proposals and quotes from various CROs.
• Review of study design, experience, CRO capabilities and quotes.
• Monitoring of clinical trial and bioequivalence studies at various CROs/clinical sites viz subject enrollment as per inclusion and exclusion criteria, compliance of study conditions as per approved protocol, study drug dosing, Biological sample analysis, Adverse event management and reporting if occurred etc.
• Meticulous planning and tracking of the clinical trial and clinical studies and deliverable as per the defined timeline of regulatory submission. Apply Biopharmaceutical Classification System (BCS) in data evaluation and design of the study.
• Investigate the clinical study outcomes by pharmacokinetics, in vitro dissolution tests, PK modeling & simulations to find out the scientific reasons related to BE failures and have a discussion for deciding the further developmental strategies with management.
• Review and revision of master service agreement (MSA) and rate contracts.
• Preparation of regulatory responses
• Coordination among CFT (cross function team)
• Any other additional responsibilities assigned by Manager