Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Site Manager II, Early Development & Clinical Pharmacology to be remote-based in 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 and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

A Site Manager II in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of complex early development and/or clinical pharmacology studies. A Site Manager II is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements, applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA, Trial Manager (TM) and Global Trial leader (GTL) 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.

Key Responsibilities:

• Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
• Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies. Responsible for the implementation of ARBM (Analytical Risk Based Monitoring) model at the site level when applicable. Monitors study progress at site using study specific systems and available reports/dashboards.
• Ensures site staff have current GCP and vital protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site and sponsor level.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• In collaboration with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensures strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried accounted and returned as applicable including maintenance of accurate and complete documentation.
• Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
• Ensures accuracy, validity and completeness of data collected at trial sites. Ensures appropriate measures are in place for maintenance of the blind when applicable
• Ensures that all Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure 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 systems used for trial management.
• Maintains complete, accurate and timely data and crucial documents in systems used for trial management
• Fully documents trial related activities with respect to study monitoring. Writes visit reports and address follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
• Reviews investigator site File for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
• Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.
• Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or inspection 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.
• May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.

Qualifications

Education:

• 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 2-3 years of clinical trial monitoring experience is required.
• Prior Experience in monitoring Phase-One studies is required.

Preferred:

• 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 constantly evolving environment.
• Ability to work on multiple trials in parallel in different disease areas.

Other:

• Willingness to travel with occasional/regular overnight stay away from home depending on the region.

The anticipated base pay range for this position in San Francisco Bay Area, CA is MIN $96,900 to MAX $156,055.

The anticipated base pay range for this position is MIN $84,000 to MAX $135,700.

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

Additional information can be found through the link below.

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.