Site Manager - Cross Therapeutic Area - Southeast U.S. - Johnson and Johnson
Raritan, NJ 08869
About the Job
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.
A 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 Site Manager I 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. May contribute to process improvement and training.
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 any time 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.
• Supplies 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 accurately inventoried and documented.
• Arranges for the appropriate destruction of clinical supplies.
• Ensures site staff complete data entry and resolve queries within the 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 documented 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.
• Supervises 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 contribute to process improvement and training. Qualifications
• A minimum of a Bachelor's degree in Life Sciences, Nursing or related scientific field is required
• Strong computer skills and ability to learn new systems is required
• 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 issues in the United States
• A minimum of 1 year of clinical trial monitoring experience is preferred
• Solid understanding of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines is preferred
• Strong written and verbal communication skills
The anticipated base pay range for this position in San Francisco Bay Area, CA is $81,000 to $129,605. The anticipated base pay range for this position in all other US locations is $70,000 to $112,700.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
