Clinical Site Manager

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, we’re 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 that’s 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 [https://www.jnj.com/medtech](https://www.jnj.com/medtech)

#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:

• Bachelor's 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
• Master's Degree or equivalent with Experience working in a regulated industry preferred
• Ability to travel up to 50% (throughout the US), as required