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Job Description:

Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two Clinical Research Leader positions. One position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site. The other position requires up to 50% travel for site visits. The field-based role can be done remotely. For the role that can be done remotely, 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.

This role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization.

Key Responsibilities:

This Clinical Research Leader will 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.

In accordance with all applicable federal, state and local laws/regulations and Corporate JnJ MedTech, procedures and guidelines, this position:

• Serves 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.
• 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 (e.g. 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 support 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, collaborates 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.
• 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 R& D 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 the clinical trial sites.
• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
• Is 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);
• Supports planning, track and manage assigned project budgets to ensure adherence to business plans.
• Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
• May serve as the clinical representative on a New Product Development team.
• May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
• Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);
• May perform other duties assigned as needed.
• Is 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.
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
• Should develop a strong understanding of the pipeline, product portfolio and business needs.
• Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.
• Responsible for communicating business related issues or opportunities to next management level.

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications:

• Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required

Or

• Master’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required

Or

• PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required

• Experience with project/team leadership is required.

• Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

• Medical device experience highly preferred.

• CRO experience and site management and clinical site monitoring are assets.

• Experience delivering presentations and writing clinical reports is preferred.

• One position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled. Travel for this position will be up to 20%. The other position will require up to 50% travel.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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