Job Location: Bangalore/Bengaluru
Job Purpose
- The role is primarily responsible for the technical development of electronic Data capture (eDC) and/or Electronic PatientReported Outcomes (ePRO) solutions and/or the technical acquisition of vendor data to support the delivery of data acquisition and related processes for one or more studies.
- This role may act as a Subject Matter expert for one or more data acquisition applications/processes.
Key Responsibilities
- Performs the study set-up activities and the technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical study(ies).
- Assist with the technical & vendor oversight of multiple data types for one or more clinical study(ies)
- Support the delivery of one or more Clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required.
For studies, Key Responsibilites Include:
- Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
- Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations)
- Understands, mediates and solves issues related to Data acquisition Develops the study eDC application and associated documents including forms, data validation checks & data extraction and ensures delivery with quality and on time
- Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities
- Ensures quality control of deliverables
- Provide inputs to process improvements, new processes, training, quality assessments, audits and inspections related to the Data Acquisition.
- Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.
- Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable).
- Breadth/Scope of Accountability – Provide details of any scope data relevant to the role e.g. the net sales that the role supports / generates or budget responsibility.
Knowledge/Education Required Minimum Level of Education Required Area of Specialization
- Bachelors or equivalent Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
- The role will require understanding Complex processes, study designs and systems in the pharmaceutical industry Only complete documents can be evaluated.
Submit CV To All Data Science Job Consultants Across India For Free
🔍 Explore All Related ITSM Jobs Below! 🚀
✅ Select your preferred “Job Category” in the Job Category Filter 🎯
🔎 Hit “Search” to find matching jobs 🔥
➕ Click the “+” icon that appears just before the company name to see the Job Detail & Apply Link 📝💼
Leave a Reply