Clinical Site Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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Job Description:

We are searching for the best talent for Clinical Site Manager

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats reimagining how we heal Our Cardiovascular team develops leading solutions for heart recovery electrophysiology and stroke. You will join a proud heritage of continually elevating standards of care for stroke heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at is a remote role available in all states/cities 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.

Responsibilities:

Serve as Subject Matter Expert (SME) for monitoring and site management activities conducted on assigned clinical studies

Review of study level trends escalations and action items to ensure overall site management

efficiency

Review monitoring visit reports to ensure compliance with Abiomed procedures and study plans

Serve a critical role as liaison and facilitate meetings between project stakeholders to ensure study tasks and deliverables are on track

Provide direction and guidance to execute project deliverables in collaboration with

project/program managers

Provide strategic direction on field monitoring of studies and data collection for clinical

trials with increased volume and complexity (e.g. KOL site) act as a Core Team lead assess all

data documentation reports records transcripts exam results for consistency with case report

form and determine if clinical trial/study subject documentation is within parameters of study

hypothesis as well as to monitor clinical trial/study safety in keeping with protocols GCP (Good

Clinical Practices) and regulatory requirements

Lead in the development of technical training on GCPs protocols database compliance device

accountability adverse event reporting study investigation protocols amendments regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities

Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees

Develop Clinical Research Associates to increase business acumen and functional skills; act as a

mentor to new or junior level employees

Support the development of site training recruitment and required study related content and

materials

Support CRAs through study start up process ensuring collection of appropriate documentation

and timely review of documentation including but not limited to budgets clinical research

agreements and informed consents

Participate in development and validation of case report forms when applicable

Review and complete checklist on informed consent forms (ICF) as needed

Develop a familiarity with the protocols to ensure adherence to study timelines inclusion and

exclusion criteria and enrollment goals

Support of review of Standard Operating Procedures (SOPs); Work Instructions and engagement in process improvement initiatives

Support conduct of Site Initiation Visits; train site personnel on sponsor and regulatory

requirements for study conduct; participate in and/or conduct site meetings and prepare site

initiation visit reports and associated documentation

Support conduct of Site Monitoring (Site Management or Interim Monitoring Visits) Visits and

follow-up to identify significant problems and issues and to ensure that all clinical aspects of

studies are being carried out in accordance with study

Support conduct of Site Close-out Visits and follow-up to ensure all site related activities and documents are complete and filed in the eTMF

Develop tools trackers and project specific training materials

Assist in the auditing of clinical trials

Qualifications:

• Bachelors Degree or equivalent in science-related field with at least 5 years previous field monitoring experience
• 2-3 years in a Lead CRA or project management type of role
• Experience with electronic data capture and Clinical Trial Management Systems required (Veeva Vault CTMS/eTMF and Medidata/Rave EDC preferred)
• Prior experience supporting trials for Class II/III medical devices
• Familiarity with quality assurance/control processes and regulatory compliance
• Proven expertise in MS Office Suite including Word Excel and Adobe
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving organizational analytical and critical thinking skills
• Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA/Project Management certification) preferred
• Masters Degree or equivalent with Experience working in a regulated industry preferred
• Ability to travel up to 50% (throughout the US) as 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 please contact us via or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $109000 - $174800.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Companys 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. For additional general information on Company benefits please go to: - This job posting is anticipated to close on August 8 2026. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

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