Senior Clinical Project Manager

Company: Disability Solutions
Location: Danvers
Posted on: February 5, 2025

Job 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 East coast or Mid west region of United statesThe 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 --- 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.\rPrimary Duties and Responsibilities:

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• 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 de---ned, 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\r\r

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