Role: Senior Research Associate/ Assistant Scientist – Bio- Clinical Studies
Reporting to: Associate Director – Bio-Clinical Studies
Location: Hyderabad
Experience: 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 projects
Key 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.
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