Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Clinical Data Management

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for our Senior Data Acquisition Expert to be located in Spring House, PA; Horsham, PA; Raritan, NJ; or Titusville, NJ.

Purpose: The Senior 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 Senior 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), eSource and/or External Data Stream systems at the trial and/or program level. This position will be able to independently perform work activities, 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.
• Lead or 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 eSource role-specific responsibilities:

Data Acquisition Expert eSource role-specific responsibilities:

• Accountable for the setup & maintenance of eSource within assigned trial(s)/program according to best practices and defined guidelines.

To include but not limited to data domain, vendor and geographical expansion.

ePRO, eSource, EHR, Real World data and traditional and novel clinical data streams.

• 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.

Qualifications / Requirements:

• Bachelor's degree (e.g., BS, BA) is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
• A minimum of 4 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry is required.
• In-depth knowledge of data management practices (including tools and processes) is required.
• In-depth knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., HL7 FHIR) is required.
• Advanced project and risk management skills with an established track record delivering successful outcomes is required.
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors is required.
• Excellent communication, leadership, influencing and decision-making skills is required.
• Excellent written and verbal communications skills is required.
• Innovative thinking to allow for optimal design and execution of clinical development strategies is preferred.
• Development and implementation of a business change/innovative way of working is preferred.
• 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 is preferred.

Required Skills:

Preferred Skills:
Advanced Analytics, Clinical Data Management, Clinical Operations, Collaborating, Communication, Database Management, Data Privacy Standards, Data Quality, Data Savvy, Good Clinical Practice (GCP), Innovation, Interdisciplinary Work, Problem Solving, Process Improvements, Research Ethics, Resource Allocation, Training People

The anticipated base pay range for this position is :
$109,000.00 - $174,800.00

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave - 80 hours in a 52-week rolling period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits