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Analyst II EDC Data Acquisition Expert – Mumbai/Bangalore/Hyderabad-
2406219185W
Integrated Data Analytics and Reporting (IDAR)
Analyst II EDC Data Acquisition Expert
Data Acquisition Expert – Electronic Data Capture
(*Title may vary based on Region or Country requirements)
Position Summary:
The Analyst II Data Acquisition Expert is an experienced individual contributor with a deep understanding of data acquisition capabilities, practices, methods, processes, and technologies. In this role, the Analyst II Data Acquisition Expert contributes to the delivery of the J&J R&D portfolio through the setup and management of Electronic Data Capture (EDC) and/or External Data Stream systems at the trial level. This position involves minimal supervision, a lead role, and may include coaching/mentoring others.
This role reports to Data Acquisition Functional Leadership and represents Data Management in cross-functional discussions, influencing key stakeholders and contributing to strategic decisions. This role may also participate in continuous improvement initiatives and industry workgroups, building strong, productive relationships with key stakeholders within IDAR, Global Development, external suppliers, and/or industry groups.
Principal Responsibilities:
- 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 manage issue escalations with appropriate escalation pathways.
- Anticipate, detect, prevent, and manage risks and issues impacting deliverables and activities.
- Contribute to the development and maintenance of departmental policies, procedures, training, and standards.
- Support the development of functional vendor contracts and oversee delivery per agreed milestones and scope of work, R&D business planning, and budget estimates.
- Enhance functional, technical, and scientific capabilities within data management.
- Influence the external industry and/or regulatory environment through active engagement in industry forums and workgroups.
- Support data acquisition-related aspects of regulatory inspections and internal audits, ensuring real-time inspection readiness for all deliverables.
This position may be specialized in the following roles based on business needs: Data Acquisition Expert EDC, Data Acquisition Expert External Data.
Data Acquisition Expert EDC Role-Specific Responsibilities:
- Accountable for the setup and maintenance of Electronic Data Capture systems (e.g., Medidata Rave) within assigned trials according to best practices and defined guidelines.
- Activities/deliverables include, but are not limited to, translating protocol into CRF layouts, creating fit-for-purpose visit schedules accommodating study design, and implementing EDC integrations (e.g., CTMS, IWRS, Safety Gateway, tSDV, coding, data mart mappings).
- Actively participate in continuous improvement initiatives; define and implement changes to enable an industry-leading EDC data acquisition capability.
Principal Relationships:
- Internal: Reports to a people manager within the functional area (e.g., Data Acquisition Leader). Functional contacts within IDAR include Leaders and/or leads in Data Management, Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Leads, and system support teams.
- J&J Innovative Medicine: Collaborates or works as a peer with Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources, and Project Coordinators.
- External: Includes interactions with external partners and suppliers, CRO management, vendor liaisons, industry peers, and workgroups.
Qualifications
Education and Experience Requirements:
Required:
- Bachelor’s degree (e.g., BS, BA) or equivalent professional experience in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
- Approximately 2 years of experience in the Pharmaceutical, CRO, Biotech industry, or related fields.
- Proven knowledge of data management practices, including tools and processes.
- Familiarity with regulatory guidelines (e.g., ICH-GCP) and standards (e.g., CDASH, SDTM).
- Intermediate project and risk management skills with a successful track record in delivering outcomes.
- Demonstrated experience collaborating with multi-functional teams in a matrix environment and managing stakeholders, customers, and vendors.
- Strong communication, leadership, influencing, and decision-making skills.
- Proficient in written and verbal English.
- Technical expertise in building and maintaining EDC systems (e.g., Medidata RAVE) and associated integrations (e.g., CTMS, IWRS, Safety Gateway, tSDV, coding, data mart mappings).
Preferred:
- Innovative thinking to optimize clinical development strategy design and execution.
- Ability to contribute to the development and implementation of business change and innovative processes.
- Experience with data from EHR/EMR, Digital Health technologies, Real-World Data, EDC systems, EDC integration tools, and general data capture platforms.
Other: Approx. <10% travel (domestic or international) may be required.
Primary Location: Asia Pacific – India – Maharashtra – Mumbai
Organization: Johnson & Johnson Private Limited (8080)
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