Senior Clinical Project Manager

Johnson & Johnson; Danvers (MA); On-site; USD 100,000 - 173,000; Full time

Job summary

An established industry player in healthcare innovation seeks a Senior Clinical Project Manager to lead clinical studies focused on cardiovascular health. This role involves comprehensive study management, ensuring compliance with GCP/ICH guidelines, and collaborating with various stakeholders to drive project success. The ideal candidate will have extensive experience in clinical research, particularly within the medical device sector, and possess strong project management skills. This is a fantastic opportunity to contribute to groundbreaking healthcare solutions that improve patient lives while working in a dynamic and fast-paced environment.

Qualifications

• 8+ years of experience in clinical research, including leadership in medical device industry.
• Expertise in GCP and regulatory compliance for clinical trials.

Responsibilities

• Manage operational activities for assigned clinical studies ensuring compliance with regulations.
• Lead core team meetings, track goals, issues, and risks effectively.

Skills

Clinical Research

GCP Compliance

Project Management

Communication Skills

Risk Management

Education

Bachelor of Science (BS) in Science, Engineering, or related field

Master of Science (MS) or advanced degree

Job description

Job Description - Senior Clinical Project Manager (2506234908W)

Senior Clinical Project Manager - 2506234908W

Description

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 the East Coast or Midwest region of the United States.

The Sr. Clinical Project Manager reports to the Director, Clinical Affairs and will manage the operational activities for assigned Abiomed Clinical Study(ies). The Sr. Clinical Project Manager will plan, develop and follow systems and procedures to ensure optimum compliance in accordance with GCP/ICH guidelines and FDA regulations, operating quality and efficiency. 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 vendors, including Core Labs and DSMBs/CECs.

Responsibilities:

1. In collaboration with Senior Clinical Program Manager and/or Medical Director, responsible for comprehensive study management.
2. Lead core team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks, and actions are appropriately tracked.
3. Effectively manage enrollment of high-risk patients in a fast-paced environment.
4. Responsible for project development, performance tracking and risk management associated with study management and clinical monitoring visit and report compliance.
5. Responsible for the management of project specific vendors, including Study Committees, CRO/ARO, Core Labs, and DSMBs/CECs.
6. 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.
7. Accountable for the conduct of clinical research programs in accordance with approved project plan, budgets, SOPs, and applicable regulations.
8. Support analysis and development of action plans for investigational sites, vendor management, non-compliance, and administrative issues.
9. Plan, prepare and present at Investigator and Research Coordinator Meetings, as applicable.
10. Provide Quality Assurance, including management-level representation during audits and inspections, as applicable.

Qualifications:

1. Direct experience successfully conducting 510(k) and/or IDE studies, including Pre/Post-Market clinical strategies, to align with business objectives.
2. Bachelor of Science (BS) degree in Science, Engineering, or related medical/scientific field.
3. Minimum of 8 years relevant experience.
4. Minimum of five (5) years of experience in clinical research with at least two years in the medical device industry in a leadership role.
5. Expertise with GCP and regulatory compliance guidelines for clinical trials.
6. Polished communication and presentation style.
7. High attention to detail and accuracy; excellent prioritization, organizational skills and advanced, metric-driven project management skills.
8. Positive, self-starter, willing to work in an extremely fast-paced environment looking for growth and making a difference in patient lives.
9. Willingness and ability to travel up to 35% to support study initiatives, as required.

Preferred Qualifications:

1. Master of Science (MS) or graduate/advanced degree.
2. Experience with Class III cardiovascular devices strongly preferred.
3. Experience with site and sponsor level FDA BIMO investigation(s).

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 $172,500.

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.