Analyst II External Data Acquisition Expert - Mumbai/Bangalore/Hyderabad

ence key stakeholders and contribute to strategic discussions and decisions. This position may also participate in continuous improvement initiatives and industry work groups.

This position develops strong and productive working relationships with key stakeholders within IDAR and Global Development, in addition to broader partners, 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 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.

This position may be specialized into the following roles based on business needs: Data Acquisition Expert External Data

Data Acquisition Expert External Data role-specific responsibilities:

• Accountable for the setup & maintenance of External Data Streams within assigned trial(s) according to best practices and defined guidelines.

• External Data Streams include but not limited to ePRO, eSource, EHR, Real World data and traditional and novel clinical data streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS).

• Activities/deliverables include but not limited to development of trial specific data transfer agreements & specifications, verification of data transfers, and setup of automated data ingestion into the clinical data repository.

Principal Relationships:

• Reports into people manager position within functional area (e.g., Data Acquisition Leader).

• Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.

• Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators.

• External contacts include but not limited to: External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups.

Qualifications

Education and Experience Requirements:

Required

• 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. 5+ 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 developing and maintaining External Data Streams (e.g., Labs, ECG, Biomarkers, PK/PD, PGx, IVRS) and associated components (e.g., Data Transfer Agreements & Specifications, transfer file verification, data ingestion set-up).

Preferred

• 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.

Other:

• Approx. < 10% travel (domestic or international) may be required.