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:

US026 PA Spring House - 1400 McKean Rd, US063 NJ Raritan - 920 US Hwy 202, US306 NC Morrisville - 5151 McCrimmon Pkwy

Job Description:

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

We are searching for the best talent for Analyst II, Clinical Data Manager to be remote in the United States.

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Purpose:

The Analyst II Data Manager is a professional individual contributor role at junior level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. The Analyst II Data Manager makes recommendations and influences decisions for specific trials or assignments. This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML). Work is received in broad terms. Work is reviewed on an ongoing basis with Data Management Leader and the amount of instruction is limited.

You will be responsible for:

• Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to:
  • Gather and/or review content and integration requirements for eCRF and other data collection tools.
  • Establish conventions and quality expectations for clinical data. o Establish expectations for dataset content and structure.
  • Set timelines and follow-up regularly to monitor delivery of all data management milestones.
• Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.
• Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.
• Plan and track content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
• Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
• Identify and participate in process, system, and tool improvement initiatives.
• Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS, and Study Responsible Physician related queries in EDC system. Involvement in other clinical data review activities (e.g., Coding, SAE reconciliation) is possible.
• Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.

Qualifications:

Education:

• Minimum of a 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).

Required:

• Minimum of 2 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Experience in clinical drug development within the pharmaceutical industry or related industry.
• Experience working with cross functional stakeholders and teams.
• Strong written and verbal communications skills (in English).

Preferred:

• Team leadership experience.
• Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.
• In-depth knowledge of current clinical drug development processes.
• In-depth knowledge of applicable international guidelines regarding data management of clinical trials.
• Knowledge of technology platforms and systems to capture and process data as well as understanding of data privacy rules in relation to clinical data exchange.

Other:

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

The anticipated base pay range for this position is $77,000 to $124,200.

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

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

Additional information can be found through the link below.

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

This job posting is anticipated to close on 03/17/25. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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 :

$77,000 to $124,200

Additional Description for Pay Transparency:

The anticipated base pay range for this position is $77,000 to $124,200. 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 Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits. This job posting is anticipated to close on 03/14/25. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.