Clinical Research Manager JJMT Electrophysiology

Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions 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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats 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 limited supervision this Clinical Research Manager will provide leadership to a team of Clinical Research Leaders (CRLs) and Clinical Research Specialists (CRSs) and ensure the successful performance and delivery of project deliverables on time with high quality. The Clinical Research Manager will be responsible for encouraging strong positive relationships with co-workers across the organization.

Key Duties/Responsibilities

• Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials ensuring monitoring compliance with timelines and study milestones for JNJ MedTech - Electrophysiology
• Provide leadership and oversight for monitoring activities of clinical trials aligning activities with broader study objectives and providing input on trial design to optimize monitoring efficiency and effectiveness
• Experience documenting and sharing insights into trial monitoring activities (e.g. trends in protocol compliance enrollment monitoring deviations data quality); external partners e.g. principal investigators and support staff and internal partners e.g. study team management and leadership staff
• Contribute to the oversight of feasibility selection set up conduct and closure of a clinical trial as related to monitoring activities within the allocated countries in accordance with the ICH-GCP applicable legislation and Company Standard Operating Procedures
• Perform monitoring activities including site qualification visits site initiation visits interim monitoring visits or close out visits
• May be involved in the management and oversight of device ordering tracking and accountability of investigational products and trial materials
• May be involved in the teams interface and collaboration with key opinion leaders site investigators IRBs/ECs Regulatory agencies contractors/vendors societies associations and company personnel
• Provide input on clinical data review to prepare data for statistical analyses and publications
• Lead on-site procedural protocol compliance and data collection to the clinical trial sites
• Is responsible for delivery of monitoring deliverables for 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)
• May liaise with regional partners to ensure global standard processes are shared and applied across the organization
• Plans tracks and manages assigned monitoring project budgets to ensure adherence to business plans
• Ensures resources assigned to designated clinical trials to provide quality deliverables while maintaining efficiency
• Functions as a reliable trusted resource of accurate up-to-date project knowledge as requested by key stakeholders
• Should develop a strong understanding of the pipeline product portfolio and business needs
• Manages work independently. Independently solves problems arising during clinical trial execution and will seek guidance for more complex problems as needed;
• 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 :

Required Education & Skills/Experience:

• Minimum of a bachelors degree in Life Science Physical Science Nursing or Biological Science or other related field with at least 8 years clinical research experience is required

OR

Masters degree in Life Science Physical Science Nursing or Biological Science or other related field with at least 7 years clinical research experience is required

OR

PhD in Life Science Physical Science Nursing or Biological Science or other related field with at least 5 years clinical research experience is required

• Previous experience in managing or supervising global clinical trials
• A minimum of 2 years leadership / management role within Clinical Research including 1-2 years of people management experience is required.
• Clinical project leadership across multiple studies/ programs is required.
• Experience working well with cross-functional teams is required.
• Experience with budget planning tracking and control is required.
• Medical Device experience is required.

Preferred Education & Skills/Experience:

• Bachelors Degree in Life Science Physical Science Nursing or Biological Science is preferred.
• Relevant industry certifications are preferred (i.e. CCRA CCRC CCRP RAC CDE GCP ISO 14155 MDR ).
• Clinical/medical background is a plus.

Other:

• This position may require up to 25% travel 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 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 () or contact AskGS to be directed to your accommodation resource.

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