Job Description

Integrated Data Analytics and Reporting (IDAR)
Analyst II EDC Data Acquisition Expert*
(*Title may vary based on Region or Country requirements)Position Summary:
The Analyst II EDC Data Acquisition Expert is an experienced individual contributor with an in-depth understanding of data acquisition capabilities, practices, methods, processes, and technologies. In this role the Analyst II Data Acquisition Expert contributes to delivery of the J&J R&D portfolio through accountability and/or execution of the set-up and management of Electronic Data Capture (EDC) systems at the trial level. This position will be able to perform work activities with minimal supervision, take a lead role, and may coach/mentor others.
This position reports to Data Acquisition Functional Leadership and represents Data Management in cross functional discussions, with the ability to influence 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 EDCData 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. 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 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 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.

eQuest