- Are you a person with innovative thinking and proactive attitude with continuous improvement as one of your career objectives?
- Join Global Development team at our company and get a life-changing career!
About the department
- GD -GSC-Clinical Data & Systems Support Unit supports Projects and Trial Management on DM tasks that are other than operational data management activities on clinical projects.
- These includes functions and roles covering Functional Supporters, eLoader, ePRO Operations Specialist, Titration report specialist, EDC Report Specialist, EDC-IVRS Interface Specialist, EDC Operations Specialist, Change Manager, Standards Supporter (Database Setup with CDW Mapping), CMC Coordinator, Functional Programmers etc.
- All in all it’s a Dynamic, Diverse and Vibrant unit committed to ClinOps mission of “We unite People, Performance, and Process together” team with a fall-back infrastructure of good clinical and technical knowledge.
- Generate Standard and custom / adhoc reports
- Understand stakeholder needs on reports and prepare specifications
- Program new and / or customize existing programs as per specifications using programming language eg: SQL / PLSQL / SAS etc., that utilize data from multiple source such as IMPACT, OC, CDW, IVRS ePRO etc.,
- Generate standard and/or customize existing reports as relevant for .e.g. Projects, Study Groups, Management, Titration group, Data Review group etc…
- Generate ad-hoc reports eg : AESI, Data Cleaning cycles, Protocol deviations, Site Data Entry statuses, Subject lists etc.. for stakeholders
- Maintain report-related documentation
- Conduct and/or chair report meetings
- Provide inputs to process improvements and training
- M.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.
- Minimum 2-4 years of experience in pharmaceutical industry and preferably 2 years within clinical data management systems.
- Expert knowledge on computer systems and IT
- Knowledge of validation of computer systems
- Project management knowledge
- In-depth knowledge of drug development and basic medical terminology
- Technical skills; ability to see technical solutions matching specific data or data base challenges.
Working with Us:
- 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