Senior Site Manager, Cross Therapeutic Area - Western U.S. - 2306158003W

　　Description

　　Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Site Manager, Global Clinical Operations - Cross TA . This position can be located remotely in the Western Region (AZ, CA, CO, ID, MT, NE, ND, NM, NV, OR, SD, UT, WA, WY, HI, AK) of the United States.

　　At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

　　A Senior Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. This individual will be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), 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 Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers.

　　Primary responsibilities:

　　Acts as primary local company contact for assigned sites for specific trials

　　Participate in site feasibility and/or pre-trial site assessment visits

　　Attends/participates in investigator meetings as needed

　　Responsible for performing 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

　　Responsible for the implementation 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

　　Ensures site staff are trained and the corresponding training records are complete and accurate at anytime point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in the shortest possible timeframe

　　Contributes to site level recruitment strategy and prioritization and implementation in partnership with other functional areas

　　Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct

　　Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and detailed

　　Arranges for the appropriate destruction of clinical supplies

　　Ensures site staff complete data entry and resolve queries within expected timelines

　　Ensures accuracy, validity and completeness of data collected at trial sites

　　Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and detailed as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents

　　Maintains complete, accurate and timely data and crucial documents in relevant systems used for trial management

　　Fully documents 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 team members

　　Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times

　　Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team

　　Attends regularly scheduled team meetings and trainings

　　Aligns with relevant training requirements. Act as local authority in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities

　　Works closely with LTM 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, e.g. On Site Quality Monitoring Visit (OSQMV)

　　Prepares trial sites for close out, conduct final close out visit

　　Tracks costs at site level and ensure payments are made, if applicable

　　Establishes and maintains good working relationships with internal and external team members in particular investigators, trial coordinators and other site staff

　　May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate

　　Acts 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

　　Leads and/or participates in special initiatives as assigned

　　May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”

　　Qualifications

　　Qualifications

　　A minimum of a Bachelor’s degree in Life Sciences, Nursing or related scientific field is required

　　A minimum of 2 years of clinical trial monitoring experience is required

　　Solid understanding of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines is required

　　Strong computer skills in appropriate software applications and related clinical systems is required

　　Strong written and verbal communication skills

　　Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights/week on average) is required

　　A valid Driver's License issued in the United States

　　The anticipated base pay range for this position in San Francisco Bay Area, CA is $101,000 to $162,725. The anticipated base pay range for this position in all other US locations is $88,000 to $141,450.

　　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 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)).

　　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

　　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-New Jersey-New Brunswick

　　Other Locations NA-US-Oregon, NA-US-Washington, NA-US-Wyoming, NA-US-North Dakota, NA-United States, NA-US-California, NA-US-Nebraska, NA-US-Idaho, NA-US-New Mexico, NA-US-South Dakota, NA-US-Arizona, NA-US-Montana, NA-US-Utah, NA-US-Nevada, NA-US-Alaska, NA-US-Hawaii, NA-US-Colorado

　　Organization Janssen Research & Development, LLC (6084)

　　Relocation Eligible: No

　　Job Function Clinical Trial Support

　　Req ID: 2306158003W