The Parexel is looking for an interested candidate for the position of Quality Specialist Support the development and implementation of an eClinical quality framework including but not limited to process and training material design. Independently review quality and compliance criteria for technology setup for a study program / individual trial. This includes both: an eClinical environment (compilation of systems used & their integrations) & technical study setup of an individual system.
- M.sc life sciences, Pharma and/or Clinical Research
- Experience: 3-6years
|Location||Hyderabad, Telangana, India|
- Support the development and implementation of an eClinical quality framework
- Independently review quality and compliance criteria adherence for technology setup for a study program / individual trial
- Support and represent quality and compliance (in coordination with business functions) in audits, client assessments or regulatory inspections
- Advise business function on quality and compliance criteria to be met for technology setup activities
- Research and advise on relevant regulatory and industry trends and initiatives to ensure company stays current on GxP compliance issues with respect to technology integrations and study technology setup activities.
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.