Standards Specialist - India
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About the department
- Clinical Data & Systems Support, Global Development GSC comprises of efficient and qualified team which is mainly responsible for providing diverse functional and system support to execute clinical trials across PDP portfolio. The team has strong understanding of our company Clinical systems and is involved in :
- Database set-up, integration of system interfaces at trial level and user access management on clinical systems
- Supporting SDTM mapping, SAS programming to enable CDISC submissions
- End-to-end standardization of data flow across systems
- Clinical data tracking reports for trial management
- Technical knowledge in programming and automation
- Representation in control of standards foras, international study group meetings etc.,
- Ensure design, set-up of study database for clinical trials are aligned across trials within project
- Mapping of clinical data and metadata from source system(s) to CDW.
- Support system releases.
- Coordinate tasks related to SDTM Programmer activities dealing with both internal and external resources.
- Share better practices and use of standards.Provide Business support.
- Give input to maintenance of data model.
- Facilitate implementation of business processes introduced by the systems supported by CS&DM.
- Maintain and ensure consistency in communication with teams on standards adherence.
- Promote knowledge exchange for continuous improvement and quality mindset with focus on compliance
- M.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.
- Minimum 7-8 years of experience in pharmaceutical industry and preferably 6 years within clinical data management systems
- Expert knowledge on CDISC concepts & deliverables
- Expert knowledge on end to end clinical data management activities
- Expert knowledge of computer systems and IT
- Sound knowledge with analysis and design of business processes and functional design within the area of drug development
- Knowledge of validation of computer systems
- Extensive experience with collaboration across professional and regional borders
- Experience with communication and presentations
- Experience in supervision and mentoring
- Regular participation in conferences/workshops
- Experience with project management and stakeholder management
- In-depth knowledge of drug development and basic medical terminology
- Profound knowledge of GxP and guidelines within drug development
- Advanced knowledge of relational database systems and data models.
- We create value by putting patients first.
- Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us.
- Working here is not just a way to make a living, but a way to make a difference.