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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/.

Johnson & Johnson's MedTech focused on cardiovascular health, is recruiting for a Senior Clinical Project Manager to be based at East coast or Mid west region of United states

The Sr. Clinical Project Manager reports to the Director, Clinical Affairs and will manage the operational acti viti es for assigned Abiomed Clinical Study(ies). The Sr. Clinical Project Manager will plan, de v elop and f ollo w s y st ems and pr ocedur es t o ensur e op ti mum compliance in accordance with GCP/ICH guidelines and FDA regulations, operating quality and e ffi ciency. The Clinical Project Manager works closely with Clinical Research Associates, Clinical Project/Program Manager(s), Medical Affairs and Safety/Regulatory Departments to execute the trial(s). She/he may need to engage and work closely with Committee Members, CRO/AROs and various study v endors, including Core Labs and DSMBs/CECs.

Primary Duties and Responsibilities:

• In collaboration with Senior Clinical Program Manager and/or Medical Director, r esponsible for comprehensive study management

• Lead core team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks, and actions are appropriately tracked

• Effectively manage enrollment of high-risk patients in a fast-paced environment

• Responsible for project development, performance tracking and risk management associated with study management and clinical monitoring visit and report compliance

• Responsible for the m anagement of project specific vendors, including Study Committees, CRO/ARO, Core Labs, and DSMBs/CECs.

• Oversee and support the development of key study documents including, but not limited to study protocols and related amendments, study plans and procedure manuals, project tools, training materials, Informed Consent Forms and Clinical Study Reports

• Accountable for conduct of clinical research programs in accordance with approved project plan, budgets, SOPs, and applicable regulations

• Support analysis and development of action plans for investigational sites, vendor management, non-compliance, and administrative issues

• Plan, prepare and present at Investigator and Research Coordinator Meetings, as applicable

• Provide Quality Assurance, including management-level representation during audits and inspections, as applicable

Qualifications

Required Qualifications:

• Direct experience successfully conducting 510(k) and/or IDE studies, including Pre/Post-Market clinical strategies, to align with business objectives

• E xperience in Class III devices

• Bachelor of Science (BS) degree in Science, Engineering, or related medical/scientific field

• Minimum of 8 years relevant experience

• Minimum of five (5) years of experience in clinical research with at least two years in the medical device industry in a leadership role

• Expertise with GCP and regulatory compliance guidelines for clinical trials

• Polished communication and presentation style

• High attention to details and accuracy; Excellent prioritization, organizational skills and advanced, metric-driven project management skills

• Positive, self-starter, willing to work in an extremely fast-paced environment looking for growth and making a di ff erence in patient lives

• Excellent interpersonal communication skills; Works e ff ectively on cross-functional teams

• Willingness and ability to travel u p to 35% to support study initiatives, as required

Preferred Qualifications:

• Master of Science (MS) or graduate/advanced degree

• Experience with Class III cardiovascular devices strongly preferred

• Experience with site and sponsor level FDA BIMO investigation(s)

• Certified Clinical Research Professional(CCRP) and/or Project Management Professional(PMP)

This job posting is anticipated to close on February 17, 2025. 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.

The anticipated base pay range for this position is $100,000 to $172500.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

The Company maintains highly competitive, performance-based compensation programs. Under current 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 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 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)).

• 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; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

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