Job Description

:Role: Senior Research Associate/ Assistant Scientist Bio- Clinical StudiesReporting to: Associate Director Bio-Clinical StudiesLocation: HyderabadExperience: At least 7 years of industrial experience in the field of Bio-Clinical Studies with M. Pharma or 4 years of industrial experience with Ph.D.Qualification: M. Pharma/ M.S or Ph.D. (Pharmacology/Medicine) or equivalent from a reputed University.Purpose of the Role: Supporting and guiding projects through proof of concept to clinical development for LBOE Global projectsKey Deliverables:

• Support Synopsis development, planning, execution and management of early to late phase clinical development studies to achieve Clinical studies for proof of concept /registration of product in India global markets.
• Support Planning, execution and management of BA/BE studies in healthy volunteers to achieve Proof of concept /registration of products in India global markets
• Manage study activities at CROs and Global Dept.\'s to achieve Management compliance as per requirements of Ferring/GxP/ Regulatory
• Coordinate for non-clinical and clinical study supplies Investigational medicinal product (IMP, NIMP, Biological samples, etc.) to achieve IMP supply
• Support QA compliance for non-clinical GLP studies to achieve Quality compliance
• Perform and Support Review of dossier for submission to Regulatory Authority to achieve Regulatory compliance
• Perform and Support review of Bioanalytical method development validation reports to achieve High Quality data
• Perform and Support review of scientific data (PK / PD and statistical data/ results) to achieve High Quality data
• Perform and Support evaluation of clinical and non-clinical study Vendors facilitating QA audit and selection of vendors to achieve Qualified vendors.

Preferred Competencies for success in the role:

• Hands on experience in BA-BE studies.
• Experience in drug product development in early to late phase clinical development
• Hands on experience in PK-PD translation
• Exposure to non-clinical studies will be an added advantage.
• Trained in Good Clinical Practices (GCP)
• 5 years of experience in Clinical Trials and BA/BE studies management
• Experience in clinical trial supply management (IMP, biological samples, etc.)
• Thorough knowledge of regulatory ethical requirements, Quality standards, PV, etc.
• Experience in medical writing, biostatistics, Data Management, CTMS, vendor management, etc.
• Experience of trial/study monitoring and handling GxP audit and regulatory inspections, etc.

Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Please use the below Lifelancer link for job application and quicker response.

Lifelancer