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 Project Management

Job Category:

Professional

All Job Posting Locations:

Alabama (Any City), Alabama (Any City), Arizona (Any City), Arkansas (Any City), California (Any City), Colorado Springs, Colorado, United States of America, Connecticut (Any City), Danvers, Massachusetts, United States of America, Delaware (Any City), Florida (Any City), Georgia (Any City), Idaho (Any City), Illinois (Any City), Indiana (Any City), Iowa (Any City), Kansas (Any City), Kentucky (Any City), Louisiana (Any City), Maine (Any City), Maryland (Any City), Michigan (Any City), Minnesota (Any City), Mississippi (Any City), Missouri (Any City), Montana (Any City){ + 23 more}

Job Description:

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re 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 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

We are searching for the best talent for a Manager, Global Clinical Compliance. This is a remote role available in the continental USA.

Purpose: The Manager, Global Clinical Compliance is responsible for ensuring that clinical studies are executed in accordance with applicable international, federal, and local regulations, Good Clinical Practices (GCP), and Abiomed internal Standard Operating Procedures (SOPs). She/he will serve as a resource for clinical study teams to instill regulation awareness and promote a constant state of inspection readiness, inclusive of identifying potential risks and advising on solutions to ensure high quality clinical evidence is generated in support of clinical study tactical plan objectives. She/he will conduct routine quality checks of clinical studies to ensure that quality records are accurate, complete, and contemporaneous. She/he will take an ownership role of the Clinical Quality System, ensuring alignment with regulations, GCP, and corporate quality standards; leveraging internal subject matter experts (SMEs) to develop content aligned with current practice, and developing effective training programs to ensure that associates have the knowledge and skill to perform their essential duties. The Manager, Global Clinical Compliance will work closely with Quality Assurance to manage health authority inspections, schedule and align on internal audit objectives, and manage Corrective and Preventative Actions (CAPA).

You will be responsible for:

• Actively engages and collaborates with Clinical Program/Project Managers, Clinical Affairs Leadership, and other members of the internal study team to promote inspection readiness throughout the full clinical trial lifecycle.
• Identifies potential risks and advises team on solutions to ensure regulatory compliance and transparency.
• Escalates compliance risks and effectively communicates concerns with Clinical Affairs Leadership as appropriate.
• Schedules and conducts routine quality checks of clinical studies to ensure that quality records are accurate, complete, and timely.
• Develops risk-based quality driven strategies to identify, measure, and mitigate clinical study risks that are aligned with regulatory status and project scope.
• Conducts training for Clinical Affairs on regulations, guidance documents, and effective management of audits.
• Develops training plans to ensure associates have the knowledge and skill to perform their essential duties; monitors compliance to training plans.
• Responsible for the development of all Quality Plans/related documents and oversees implementation according to committed timelines.
• Assumes ownership of the Clinical Quality System ensuring compliance with global regulatory requirements/guidance and corporate operating procedures to ensure clinical studies are conducted in a controlled manner.
• Ensures SOPs are maintained current and liaises with SMEs to ensure effective content.
• Documents results of quality checks in a clear, concise, and timely manner and ensures awareness among applicable stakeholders.
• Collaborates with Quality Assurance to effectively manage “front room” activities.
• Supports Clinical CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions; track and ensure timely resolution of all Clinical CAPAs.
• Works with departmental leadership and assists in initiatives across Clinical Operations and cross functionally, aimed at improving process and efficiency.
• Constructively challenges process and assumptions to cultivate development and implementation of refined solutions.
• Provides feedback on process, execution and performance to foster continuous learning and growth of self and team.
• Applies strategic thinking to lead, plan and execute the delivery of clinical services in a compliant manner.
• Understands and examines the implications of cross functional decisions and the potential downstream effects on data quality and integrity.
• Provides mentoring/coaching and management (direct and/or indirect as requested by leadership) of new hires and/or junior associates.
• Maintains accurate and complete study records.
• Ability to perform additional responsibilities as requested.

Qualifications:

• Bachelor’s degree from an accredited university required; BS preferred in Life Sciences or related medical/scientific/technical field. Preference will be given to candidates/individuals with a Master’s degree in said disciplines
• Minimum 8 years of professional experience in a functional capacity in a CRO, pharmaceutical, biotechnology, or medical device company; Clinical Operations, Monitoring or Project Management preferred
• Minimum 4 years of experience supporting medical device studies.
• Prior Compliance/Quality experience preferred.
• Advanced Knowledge of GCP and FDA Code of Federal Regulations (21 CFR Part 11, 50, 54, 56, 812) required
• Intermediate Knowledge of International Regulations (EU MDR, ISO, Japanese GCP (J-GCP), Japanese Electronic Records/Electronic Signatures (ER/ES)) required
• Knowledge of data privacy concerns including European General Data Protection Regulation (GDPR) required
• Knowledge of clinical trial applications, including prior knowledge and experience with Veeva Vault eTMF and Medidata RAVE
• Prior Management experience preferred
• Demonstrates leadership, including the ability to coach and mentor direct reports to achieve optimal performance
• Self-motivated and leads by example
• Ability to influence cross-functionally throughout the organization.
• Dedicated to continuous improvement and enjoys the opportunity to teach those around them.
• Knowledge of computer system validation (CSV) lifecycle management and associated documentation required.
• CRO/vendor management experience desired.
• Must be computer savvy and highly proficient in Microsoft Office.
• High attention to details and accuracy; ability to work independently and to prioritize and organize work to meet deadlines.
• Excellent communication, written and interpersonal skills; Works effectively on cross-functional teams.
• Highly independent and able to prioritize and work on multiple initiatives and tasks with minimal oversight.
• Able to develop project management objectives, as needed.
• Ability to travel ~10%.

An equivalent combination of education, experience and performance may be considered.

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.

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The anticipated base pay range for this position is:

$100, 000 - $172, 500

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)). This position is eligible to participate in the Company’s long-term incentive program. 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