Clinical Research Lead - Mentor Worldwide, LLC

Mentor Worldwide LLC., part of the Johnson & Johnson family of companies, is currently recruiting for a Clinical Research Lead . The preferred location for this role is within a commutable distance of Irvine, CA however remote options within the Pacific, Mountain, or Central time zones will be considered on a case by case basis.

About Johnson & Johnson

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/.

This senior level individual contributor Clinical Research Lead will function as a Project Manager and be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

PRIMARY RESPONSIBILITIES

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for the Mentor business unit;

• Oversight/execution of 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 (e.g. site management);

• Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision;

• Ensure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov )

• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;

• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

• Oversee the development and execution of Investigator agreements and trial payments;

• Responsible for clinical data review to prepare data for statistical analyses and publications;

• If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;

• If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;

• Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;

• Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);

• Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;

• Track and manage assigned project budgets to ensure adherence to business plans;

• Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;

• Develop a strong understanding of the pipeline, product portfolio and business needs;

• May serve as the clinical representative on a New Product Development team;

• May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;

• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;

• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;

• Perform other duties assigned as needed;

The base pay range for this position is $105,000 to $155,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, [long-term incentive – include LTI only if applicable] disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

https://www.careers.jnj.com/employee-benefits

Qualifications

REQUIRED QUALIFICATIONS

Education

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required . Advanced Degree strongly preferred .

Experience

• Minimum 6 years relevant Clinical Research experience required ; ( 5 years for Masters, 3 years for PhD ).

• At least 3 years Sponsor-side Medical device experience required ; combination of Med Device& Pharma experience is acceptable for remainder .

• Experience with CRO vendor management is strongly preferred .

• Team leadership experience is required ; Contractor/Project Team minimum , FTE leadership strongly preferred .

• Database log/CSR/APR experience in driving product timelines strongly preferred .

• Previous experience in project management in clinical research is required.

• Expert experience collaborating with cross-functional teams required.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.

• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects.

• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations.

• Strong presentation and technical writing skills.

• Strong written and oral communication skills.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

This job posting is anticipated to close on 4/3/24. 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.