Standards Specialist - India
Want to know company name or location? Company managed [?]
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 OC-CDW mapping/release 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.
Working with Us:
- We use our skills, dedication and ambition to help people with diabetes.
- We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development