Senior Analyst Clinical Trial PMO

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:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

Remote work options may be considered on a case-by-case basis and if approved by the Company.

This individual will be responsible for leading one or several clinical trials within the MedTech Surgery Clinical Operations group, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution.


You will be responsible for:

• Serve as a Senior Clinical Trial Leader within the Clinical Operations group to execute company sponsored clinical trials for the MedTech Surgery Franchises
• Manage all operational activities of assigned clinical studies and clinical activities
• Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials
• Serve as a member of the clinical trial/study core team and may serve as the liaison with the Clinical Franchise and Clinical BSDM team for projects under their responsibility
• Solve problems with support from Clinical Management arising during clinical study execution, and seek guidance for more complex problems, as needed
• Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• Plan and track assigned projects budgets to ensure adherence to business plans
• Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high-quality execution of assigned clinical trials under their responsibilities
• Provide leadership within a clinical trial, ensuring that each team member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus
• Ensure efficient use of resources within the clinical study/program to provide high quality deliverables
• Reviews and provide feedback on clinical operation section of protocols with supervision.
• May mentor or train new clinical trial staff
• Support the development and implementation of new clinical systems and processes. Participates in departmental or cross-functional initiatives.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements:

Education

• Bachelor's degree or equivalent experience, preferably in Life Science, Physical Science, Nursing, or Biological Science, is required

Experience and Skills

Required:

• Requires understanding of Good Clinical Practices
• Understanding and application of regulations and standards applied in clinical areas/regions is required
• Written and oral communication skills
• Demonstrated competencies in the following areas are required:
• Leadership in a professional and ethical manner
• Technical writing skills
• Relevant industry certifications a plus (i.e., CCRA, RAC, CDE).
• Willing to travel at least 10% - 20%.

Preferred:

• At least 2 years of previous experience in clinical trial management or equivalent is required; global experience preferred
• Medical device experience a plus
• Budget management experience a plus

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 Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Remote

Required Skills:

Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

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)).

This position is eligible to participate in the Company's long-term incentive program.

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

The following link to general company benefits information MUST also be included in the posting: Please use the following language:

For additional general information on Company benefits, please go to: -