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 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 humanity. Learn more at https://www.jnj.com

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:

About MedTech

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 https://www.jnj.com/medtech

Clinical Affairs of Robotics and Digital Solutions, Johnson & Johnson MedTech, is recruiting a Senior Clinical Trial Specialist. This role is responsible for managing all operational activities of assigned clinical trials well as fostering strong, productive 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 oversee site monitoring activities for assigned clinical trials as well as operational aspects of studies.

Key Job Responsibilities:

• Executes and manages company sponsored clinical trials, ensuring compliance with timelines and study milestones.

• Oversees/executes 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 Standard Operating Procedures.

• May serve as the primary contact for clinical 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 www.clinicaltrials.gov) from study initiation through posting of results and supports publications as needed.

• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.

• Interfaces with, collaborates with and oversees Clinical Research Associates (CRAs).

• Oversees 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