Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Danvers, Massachusetts, United States of America
Job Description:
We are searching for the best talent for Clinical Site Manager
Fueled by innovation at the intersection of biology and technology, we92re 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 that92s 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
#LI-Remote
This 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:
- Bachelor92s 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
- Master92s Degree or equivalent with Experience working in a regulated industry preferred
- Ability to travel up to 50% (throughout the US), as required
The anticipated base pay range for this position is: $109,000 - $174,800.
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 corporation92s performance over a calendar/performance year. Bonuses are awarded at the Company92s 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 Company92s consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company92s long-term incentive program. Employees are eligible for the following time off benefits: Vacation 60 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington 60 hours per calendar year. Holiday pay, including Floating Holidays 60 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: -96 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 https://www.careers.jnj.com to accept additional applications.
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)
