Senior Research Associate/Assistant Scientist BioClinical Studies
7 days ago
Role: Senior Research Associate/Assistant Scientist Bio Clinical Studies
Reporting to: Associate Director BioClinical Studies
Location: Remote
Experience: At least 7 years of industrial experience in the field of BioClinical 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 Responsibilities:- Support Synopsis development planning 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 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 Departments to achieve Management compliance as per requirements of Ferring/GxP/Regulatory
- Coordinate for nonclinical and clinical study supplies Investigational medicinal product (IMP NIMP Biological samples etc.) to achieve IMP supply
- Support QA compliance for nonclinical 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 nonclinical study Vendors facilitating QA audit and selection of vendors to achieve Qualified vendors.
- Hands on experience in BABE studies.
- Experience in drug product development in early to late phase clinical development
- Hands on experience in PKPD translation
- Exposure to nonclinical 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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Remote Work: No
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