Senior Clinical Trial Leader

Johnson & Johnson • Raritan, NJ

2d • $92,000 - $148,350 • Remote

About The Position

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

Requirements

• Bachelor’s degree or equivalent experience, preferably in Life Science, Physical Science, Nursing, or Biological Science, is required
• Understanding of Good Clinical Practices
• Understanding and application of regulations and standards applied in clinical areas/regions is required
• Written and oral communication skills
• Leadership in a professional and ethical manner
• Technical writing skills
• At least 2 years of previous experience in clinical trial management or equivalent is required

Nice To Haves

• Relevant industry certifications a plus (i.e., CCRA, RAC, CDE).
• Willing to travel at least 10% - 20%
• global experience preferred
• Medical device experience a plus
• Budget management experience a plus

Responsibilities

• 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
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior