Clinical Research Leader (PM) - JJMT Electrophysiology

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: Scientific/Technology reputed company Job Posting Locations: Irvine, California, United States of America Job Description: reputed company - Electrophysiology division is currently seeking a Clinical Research Leader (PM) position. This position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site. reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Key Responsibilities:

• Serves as a Clinical Research Leader reputed company 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 reputed company 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/reputed company, 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 reputed company monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or reputed company out visits based on study need.
• May contribute to the development and delivery of appropriate global evidence reputed company strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with reputed company 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 reputed company 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, reputed company 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/ reputed company 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) reputed company 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.
• May reputed company other duties assigned as needed.
• Is responsible for communicating business reputed company 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 reputed company Federal, State, local and company regulations, policies and procedures.
• Should reputed company 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 reputed company situations.
• Responsible for communicating business reputed company issues or opportunities to next management level
• Responsible for following reputed company Company guidelines reputed company to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow reputed company Company guidelines reputed company to Health, Safety and Environmental practices and that reputed company resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with reputed company 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 reputed company 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 reputed company field with at least 5 years clinical research experience is required

Or

• PhD in Life Science, Physical Science, Nursing, or Biological Science or other reputed company 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.
• This position will require on-site work in Irvine, CA, on average up to 2-3 days weekly. Up to 25% travel is required for this role.

reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, 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. reputed company 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 ([email protected]) or contact AskGS to be directed to your accommodation resource. The anticipated reputed company pay range for this position is : $105,000 - $169,050 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under reputed company guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to reputed company 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 and/or eligible dependents may be 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. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be reputed company through the link below. https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job