Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function: Data Analytics & Computational SciencesJob Sub Function: Clinical Data ManagementJob Category: ProfessionalAll Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India:Integrated Data Analytics and Reporting (IDAR)
Analyst EDC Data Acquisition Expert*
Data Acquisition Expert Electronic Data Capture
(*Title may vary based on Region or Country requirements)Position Summary:
The Analyst Data Acquisition Expert is an individual contributor at entry level with novice understanding of data acquisition capabilities, practices, methods, processes, and technologies. In this role the Analyst Data Acquisition Expert contributes to delivery of the J&J R&D portfolio by supporting the set-up and management of Electronic Data Capture (EDC) and/or External Data Stream systems at the trial level.
This position will be able to perform work activities with ongoing direction from their functional
manager and/or leaders. This position reports to Data Acquisition Functional Leadership and may
participate in cross functional discussions. This position may also participate in continuous improvement initiatives and industry work groups. This position develops 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.
• Manage issue escalations, adopting appropriate escalation pathways.
• Contribute to early detection, prevention and management of risks and issues impacting

deliverables and activities.

• May 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.

• Support data acquisition related aspects of regulatory agency inspections and internal audits.

Ensure real time inspection readiness for all data acquisition deliverables.Data Acquisition Expert EDC role-specific responsibilities:

• Accountable for the setup & maintenance of Electronic Data Capture systems (e.g. Medidata

Rave) within assigned trial(s) according to best practices and defined guidelines.

• Activities/deliverables include but not limited to translation of protocol into CRF layouts, fit

for purpose visit schedule accommodating study design, EDC integrations (e.g., CTMS, IWRS,
Safety Gateway, tSDV, coding, data mart mappings).

• Actively participate in continuous improvement initiatives; defining and implementing

changes to enable an industry-leading EDC data acquisition capability.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.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.

• Novice project and risk management skills.
• Ability to collaborate in an environment of cross-functional stakeholders, plan and coordinate

tasks effectively.

• Ability to communicate effectively in English (written and verbal).

Preferred

• Knowledge of clinical drug development within the pharmaceutical industry or related industry.
• Understanding of data management practices (including tools and processes), regulatory

guidelines (e.g., ICH-GCP), and standards (e.g., CDASH, SDTM).

• Knowledge on building and maintaining eDC systems (e.g., Medidata RAVE)

and associated integrations (e.g., CTMS, IWRS, Safety Gateway, tSDV, coding, data mart
mappings).
Other:

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

Johnson & Johnson