Senior Site Manager (CRA)

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 Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Remote (US), Somerville, New Jersey, United States of America Job Description: We are searching for the best talent for a Senior Site Manager (CRA) to support MedTech business. Please note candidates must have access to an airport nearby due to the extensive travel requirements of the role. This is a remote role available in multiple states within the United States. While specific cities are listed in the Locations section for reference, please note they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following states where this opportunity is available: Eastern US Broadly: Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, West Virginia, Wisconsin Purpose: The Senior Site Manager (Senior SM) serves as the primary contact point 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 Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with 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 ensure overall site management while performing trial related activities for assigned protocols. The Senior SM 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 of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. • Ensure site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases. • Work in close collaboration with CTL for the activities during site activation phase to speed up the process and activate the site in 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 (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. • Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management. • Fully document trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. • Review study files for completeness and ensures archiving retention requirements are met, always including storage in a secure area. • Collaborate with the CTL for documenting and communicating site/study progress and issues to trial central team. • Attend regularly scheduled team meetings and trainings. • Comply with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. • Work closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types. • Prepare trial sites for close out, 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. • Act as a point of contact in site management practices. • May be assigned as a coach and mentor to a less experienced site manager. • May contribute to process improvement and training. • Lead and/or participate in special initiatives as assigned. • May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned as contractors/vendors, and company personnel as needed. • Responsible for communicating business related issues or opportunities to next management level. • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. • Performs other duties assigned as needed. Qualification / Requirements: • Minimum of a Bachelor degree is required; Masters or PhD/MD/PharmD is strongly preferred. • At least 2 years of relevant experience is required. • Previous clinical research experience required (CRO or Sponsor side). • Previous MedTech monitoring or equivalent experience required. • Requires understanding and application of regulations and standards applied in clinical research areas and MedTech/combination products. • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE). • Clinical/medical background a plus. • Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and Power Point). • Strong computer skills in appropriate software and related company clinical systems required. • Expert Presentation and influencing skills. • Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines). • Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required. Travel can be either Domestic or International. • A valid Driver's License issued in one of the 50 United States and a good driving record is required. Benefits Summary: • 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)). • This position is eligible to participate in the Company’s long-term incentive program. • 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 • 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 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 federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Clinical Data Management, Clinical Evaluations, Clinical Research and Regulations, Clinical Trial Protocols, Clinical Trials Operations, Communication, Data Savvy, Empowering People, Issue Escalation, Laboratory Operations, Problem Solving, Program Management, Project Support, Research and Development, Standard Operating Procedure (SOP), Study Management, Technical Credibility The anticipated base pay range for this position is : The base pay range for this position is $105,000 to $169,050. Additional Description for Pay Transparency: 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. Apply tot his job Apply To this Job