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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

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

About Innovative Medicine

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

Purpose: The Data Acquisition Leader is a highly experienced individual with an expert understanding of data management and/or acquisition strategies, practices, methods, processes, and technologies. In this role the Data Acquisition Leader directly contributes to delivery of the J&J R&D portfolio through effective leadership and accountability for Data Management delivery on large or complex clinical development and/or strategic innovation programs and projects.

This position reports to Data Management and Central Monitoring Functional Leadership and represents Data Management in cross functional discussions, influencing key stakeholders and driving strategic discussions and decisions with a high level of independence.

This position plays a critical role in the growth and development of the group and contributes to organizational effectiveness, transparency, and communication as a matrix leader driving projects, innovation, and capability growth and/or as a People Manager, through the recruitment, onboarding, performance management, and development of people while building an inclusive and diverse working environment.

In addition, the Data Acquisition Leader plays a critical role in change leadership and driving the enhancement of functional, technical and/or scientific capabilities, processes, and tools within the function.

You will be responsible for:

• Drive the strategy and planning, execution, and completion of all data management activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency.
• Proactively evaluate and manage resource demand, allocation, utilization, and delivery to meet current and future business needs. 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 departmental deliverables and activities.
• Collaborate with internal cross-functional colleagues and external partners to define the data integration strategy for assigned programs/projects.
• Collaborate with external partners on data management related deliverables including co-development programs.
• Ensure staff/team compliance with department SOPs, policies, and regulatory guidance documents.
• 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 delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates.
• Drive 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.
• May serve as a business process or system owner for Data Management Processes or Systems.
• May provide people leadership with responsibility for hiring, attracting, and retaining top talent, performance management, career development and HR administration for direct reports. May also take responsibilities of second level line management (i.e. leader of leaders).
• Accountable for Clinical Data Acquisition delivery within assigned area and scope including setup and management of data collection tools and/or acquisition of external data streams including but not limited to EDC, EHR, ePRO, eSource, EHR, Real World data and traditional and novel clinical data streams.
• Serve as the Clinical Data Acquisition primary point of contact for assigned area and scope.
• In collaboration with Functional Leadership, define the data acquisition strategy and sourcing/operating model for assigned programs.
• Support data acquisition related aspects of regulatory agency inspections and internal audits. Coordinate real time inspection readiness for all data acquisition deliverables.
• If people leader, typically provides people management for Data Acquisition Experts within assigned area and scope. May manage Data Acquisition Leaders.

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 8 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry is required.
• In-depth knowledge of site clinical care and clinical research practices (including tools and processes) is required.
• In-depth knowledge of regulatory guidelines (e.g., ICH-GCP) is required.
• Project, risk, and team management and an established track record leading teams to successful outcomes is required.
• Excellent planning and coordinating of reuse of clinical data and site clinical research data or Data Acquisition strategy and delivery is required.
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors is preferred.
• Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments is preferred.
• Excellent written and verbal communications skills are required.
• Excellent people management skills including staff performance management and people development is required.
• Innovative thinking to allow for optimal design and execution of clinical development strategies is preferred.
• Experience in 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.
• 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Quality, Data Savvy, Good Clinical Practice (GCP), Innovation, Issue Escalation, Learning Management Systems (LMS), Leverages Information, Organizing, Program Management, Regulatory Affairs Management, Research Ethics, Technical Credibility

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

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