Analyst II EDC Data Acquisition Expert Job in Mumbai at Johnson & Johnson India

Johnson & Johnson is hiring for the role of Analyst!

Responsibilities of the Candidates:

• Planning, execution, and completion of all data acquisition activities and deliverables within assigned scope, ensuring quality, compliance standards, consistency, and efficiency.
• Ensure timely and effective maintenance of functional planning systems.
• Independently and effectively manage issue escalations, adopting appropriate escalation pathways.
• Anticipation, early detection, prevention and management of risks and issues impacting deliverables and activities.
• Contribute to the development and maintenance of departmental policies, procedures, training, and standards.
• Contribute to the development of functional vendor contracts and oversee of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates.
• Contribute to the enhancement of functional, technical and/or scientific capabilities within data management.
• Influence the external industry and/or regulatory environment through active engagement in industry forums and working groups.
• Support data acquisition related aspects of regulatory agency inspections and internal audits. Ensure real time inspection readiness for all data acquisition deliverables.

Requirements:

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
• Approx. 2 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Proven knowledge of data management practices (including tools and processes).
• Proven knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., CDASH, SDTM).
• Intermediate project and risk management skills with an established track record delivering successful outcomes
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.
• Strong communication, leadership, influencing and decision-making skills.
• Strong written and verbal communications skills (in English)
• Demonstrated technical expertise building and maintaining eDC systems (e.g., Medidata RAVE) and associated integrations (e.g., CTMS, IWRS, Safety Gateway, tSDV, coding, data mart mappings).
• Innovative thinking to allow for optimal design and execution of clinical development strategies.
• Ability to contribute to the development and implementation of a business change/innovative way of working.
• Experience working with data from EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms.