Clinical Site Manager - 2406163515W

　　Description

　　Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Clinical Site Manager located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

　　Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

　　Reporting to the Senior Manager, Clinical Site Management, the Clinical Site Manager is responsible for the functional management of day-to-day aspects of site activities on assigned clinical trials. The Site Manager should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as a collaborative team.

　　Responsibilities :

　　Serve as Subject Matter Expert (SME) for monitoring and site management activities conducted on assigned clinical studies.

　　Review of study level trends, escalations, and action items to ensure overall site management efficiency.

　　Review monitoring visit reports to ensure compliance with Abiomed procedures and study plans.

　　Serve a critical role as liaison and facilitate meetings between project stakeholders to ensure study tasks and deliverables are on track.

　　Provide direction and guidance to execute project deliverables in collaboration with project/program managers.

　　Provide strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.

　　Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees.

　　Study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.

　　Develop Clinical Research Associates to increase business acumen and functional skills; act as a mentor to new or junior level employees.

　　Support the development of site training, recruitment, and required study related content and materials.

　　Support CRAs through study start up process, ensuring collection of appropriate documentation and timely review of documentation including but not limited to budgets, clinical research agreements and informed consents.

　　Participate in the development and validation of case report forms, when applicable.

　　Review and complete checklists on informed consent forms (ICF), as needed.

　　Develop a familiarity with the protocols to ensure adherence to study timelines, inclusion and exclusion criteria, and enrollment goals.

　　Support the review of Standard Operating Procedures (SOPs) and Work Instructions and engagement in process improvement initiatives.

　　Support conduct of Site Initiation Visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.

　　Support conduct of Site Monitoring (Site Management or Interim Monitoring Visits) Visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study.

　　Support conduct of Site Close-out Visits and follow-up to ensure all site related activities and documents are complete and filed in the eTMF.

　　Develop tools, trackers, and project specific training materials.

　　Assist in the auditing of clinical trials.

　　Qualifications

　　Education:

　　Bachelor's Degree in a scientific field, with at least 4 years previous field monitoring experience; Bachelor’s Degree in a non-scientific field considered, with 10 years relevant experience

　　Master's Degree with experience working in a regulated industry preferred

　　Requirements:

　　Prior experience supporting medical device trials required.

　　Previous experience in project management, quality assurance/control and/or regulatory compliance preferred.

　　Experience with electronic data capture and Clinical Trial Management Systems required.

　　Proven expertise in MS Office Suite, including Word, Excel, and Adobe.

　　Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives.

　　Excellent problem-solving, organizational, analytical, and critical thinking skills.

　　Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA/Project Management certification) preferred

　　Ability to travel up to 50%, as required.

　　This job posting is anticipated to close on 2.14.2024. 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.

　　For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $150,000. 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

　　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.

　　Primary Location NA-US-4887-Danvers

　　Organization ABIOMED Inc.(6942)

　　Job Function Clinical Trial Support

　　Req ID: 2406163515W