Senior Clinical Trial Specialist

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 Med Tech, 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.

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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 Support
Job Category:
Professional
All Job Posting Locations:
Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America
Job Description:

Clinical Affairs of Robotics and Digital Solutions, Johnson & Johnson Med Tech, is recruiting a Senior Clinical Trial Specialist. This role is responsible for leading operational activities of clinical trials well as encouraging strong, positive relationships with colleagues across the organization.

The Senior Clinical Trial Specialist ensures inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through clinical study report. The Senior Clinical Trial Specialist will conduct site monitoring activities for clinical trials as well as operational aspects of studies.

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 Med Tech, 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

About Med Tech

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

Your unique talents will help patients on their journey to wellness. Learn more at

Key Job Activities:

• Executes and leads clinical trials, ensuring compliance with timelines and study milestones.
• Oversees/drives feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company SOPs
• May serve as the primary contact for trial sites (i.e., site management).
• Develops clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
• Ensures applicable trial registration (e.g., on (Use the "Apply for this Job" box below).) from study initiation through posting of results and supports publications as needed.
• Manages/coordinates ordering, tracking, and accountability of investigational devices and trial materials.
• Partners and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Interfaces with, collaborates with and is responsible for Clinical Research Associates (CRAs).
• Coordinates and supports the development and execution of Investigator agreements and trial payments.
• Is responsible for clinical data review to prepare data for statistical analyses and publications.
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
• Ensure site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
• Ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc.), contributing to cross-functional alignment.
• May provide on-site procedural protocol compliance and data collection support to clinical trial sites.
• Independently solves problems arising during clinical study execution, and will seek guidance for more complex problems, as needed.
• Responsible for communicating…