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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 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 business related issues or opportunities to next management level.

+ Senior Clinical Trial Specialist knows, understands, incorporates, and complies with all applicable laws and regulations relating to J&J business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.

+ May be asked to provide additional support to Clinical Affairs, Robotics and Digital Solutions staff, as needed.

Job Qualifications:

Education

A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.

Experience

+ Bachelor’s degree with at least 7 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.

+ Previous clinical research experience required.

+ Previous medical device monitoring or equivalent experience required.

+ Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.

+ Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).

+ Medical background preferred.

Additional Requirements:

+ Strong computer skills in appropriate software and related company clinical systems..

+ Proficient in speaking and writing the country language, English.

+ Presentation and influencing skills.

+ Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).

+ This position is office-based located in Cincinnati, Ohio or Santa Clara, California.

+ Ability to travel approximately 25-30% depending on the phase of the program.

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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

The anticipated base pay range for this position is $105,000-$169,050/ $121,000-$194,350 Bay Area Only

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits