Job Description

Overview We are seeking a Senior Site Manager (CRA) to support the MedTech business at Johnson & Johnson MedTech. This is a remote role available in multiple states within the United States. Please note candidates must have access to an airport nearby due to the extensive travel requirements of the role. Location Remote role with listed locations in multiple states, including: Ohio, Kentucky, Tennessee, Alabama, Mississippi, Louisiana, Michigan, Indiana, Illinois, Wisconsin, Minnesota, Iowa, Missouri, Arkansas, Texas, Oklahoma, and Kansas. Specific cities are listed in the Locations section for reference and do not limit your application. Purpose The Senior Site Manager serves as the primary contact between the Sponsor and the Investigational Site. The Senior SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company SOPs, Good Clinical Practices (GCPs), and applicable regulations from study start-up through site closure. Responsibilities may include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring, and close-out activities. The Senior SM will partner with the Clinical Trial Leader (CTL) to manage activities for assigned protocols and may contribute to process improvement, training, and mentoring of other Site Managers. You Will Be Responsible For Act as primary local company contact for assigned sites for specific trials. May participate in site feasibility and/or pre-trial site assessment visits. Attend/participate in investigator meetings as needed. Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study-specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Implement an analytical risk-based monitoring model at the site level and work with site to ensure timely resolution of issues found during monitoring visits. Ensure site staff are trained, and the training records are complete and accurate at all times. Work with CTL during site activation to speed up the process and activate the site in the shortest possible timeframe. Ensure site staff complete data entry and resolve queries within expected timelines. Ensure accuracy, validity and completeness of data collected at trial sites. Ensure that all Adverse Events (AEs), Serious Adverse Events (SAEs) and Product Quality Complaints (PQCs) are reported within required timelines and documented as appropriate. Maintain complete, accurate and timely data and essential documents in trial management systems. Document trial-related activities, including monitoring; write visit reports and follow-up letters in accordance with SOPs; communicate relevant status information and issues to appropriate stakeholders. Review study files for completeness and ensure archiving retention requirements are met. Collaborate with the CTL to document and communicate site/study progress and issues to the trial central team. Attend regularly scheduled team meetings and trainings; comply with training requirements. Act as a local expert in assigned protocols; develop therapeutic knowledge to support role and responsibilities. Work with CTL to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types. Prepare trial sites for close-out and conduct final close-out visit. Track costs at site level and ensure payments are made, if applicable. Establish and maintain good working relationships with internal and external stakeholders, investigators, trial coordinators and other site staff. May be assigned as a coach/mentor to a less experienced site manager; may contribute to process improvement and training. Lead and/or participate in special initiatives and other duties as assigned. Respect Company guidelines related to Health, Safety and Environmental practices; ensure compliance with all regulations, policies, and procedures. Qualifications Minimum of a Bachelor degree required; Masters or PhD/MD/PharmD strongly preferred. At least 2 years of relevant experience required. Previous clinical research experience required (CRO or Sponsor side). Previous MedTech monitoring or equivalent experience required. Understanding and application of regulations and standards applied in clinical research and MedTech/combination products. Relevant industry certifications preferred (e.g., CCRA, RAC, CDE). Clinical/medical background a plus. Experience with computer systems (Microsoft Office: Excel, Word, and PowerPoint) and related company clinical systems. Strong organizational skills and ability to manage multiple sub-projects and deadlines. Willingness to travel approximately 50% (about 2-3 days per week, with overnight stays). A valid driver's license in the United States and a good driving record. Compensation The anticipated base pay range for this position is $105,000 to $169,050. Pay Transparency & Benefits Subject to the terms of applicable plans, employees are eligible for medical, dental, vision, life insurance, short- and long-term disability, and other benefits. Employees may participate in the company retirement plan (pension) and savings plan (401(k)). Time-off benefits include Vacation (120 hours/year), Sick time (40 hours/year; 56 hours/year for WA residents), Holiday pay (13 days/year, including floating holidays), Work, Personal and Family Time (up to 40 hours/year), Parental Leave (up to 480 hours/year), Condolence Leave (30 days for an immediate family member; 5 days for extended family), Caregiver Leave (10 days), Volunteer Leave (4 days), Military Spouse Time-Off (80 hours). Equal Opportunity Employer: 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 law. If you require accommodation during the application process, please contact us via the following link or request resources. Seniority level Not Applicable Employment type Full-time Job function Research, Analyst, and Information Technology Industries Hospitals and Health Care #J-18808-Ljbffr Johnson & Johnson MedTech

Job Tags

Full time, Temporary work, Work at office, Local area, Immediate start, Remote work, Night shift, 2 days per week, 3 days per week,

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