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Specialist, Site Manager - Oncology - Western U.S. - 2306143523WDescriptionJanssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Specialist, Site Manager. This position can be located remotely in the Western Region (AZ, CA, CO, ID, MT, NE, ND, NM, NV, OR, SD, UT, WA, WY) of the United States.The Specialist Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager is 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. 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 III assists with process improvement, training and mentoring of other Site Managers.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 and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.Key Responsibilities:
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 LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
Contribute to site level recruitment and retention strategy and contingency planning and implementation in partnership with other functional areas.
Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
Arrange for the appropriate destruction of clinical supplies.
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. Write 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, including storage in a secure area at all times.
Collaborate with LTM 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 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).
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.
May participate in the Health Authority (HA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate.
Act as a point of contact in site management practices.
May be assigned as a coach and mentor to a less experienced SM.
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”.
QualificationsEducation:
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
Experience and Skills:Required:
A minimum of 6 years of clinical trial monitoring experience is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Experience in mentoring/coaching and providing training to others SM.
Strong leadership skills, ability to lead initiatives, to act as a lead SM.
Oncology experience/knowledge is required.
Strong knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems.
Proficient in speaking and writing the country language and English.
Good written and oral communication skills.
Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
Ability to work on multiple trials in parallel in different disease areas
Ability to travel up to 65% with overnight stay away from home depending on the region.
The anticipated base pay range for this position in the San Francisco Bay Area, CA is $119,000 to $191,820. The anticipated base pay range for this position in all other US locations is $104,000 to $166,750.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-benefitsJohnson & 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-RaritanOther 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-ColoradoOrganization Janssen Research & Development, LLC (6084)Relocation Eligible: NoJob Function Clinical Trial AdministrationReq ID: 2306143523W