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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.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Analyst II, Data Acquisition Expert EDC to be in Springhouse, PA, Raritan, NJ or Titusville, NJ,

Purpose:

The Analyst II 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) and/or External Data Stream 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.

You will be responsible for:

• 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 EDC, Data Acquisition Expert External Data

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.

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/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. 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)

• For DAE EDC role, 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).

• For DAE External Data role, 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$89,000.00 - $143,750.00 USD

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.