Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Site Manager - Early Development and Clinical Pharmacology. This position can be located remotely within the United States.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
The Senior Site Manager - Early Development and Clinical Pharmacology (ED&CP) will serve 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. This individual will be assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOPs), 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. Partner with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Clinical Development Operation (GCDO) Trial Leader (GTL), and Independent Drug Monitor Manager (IDMM) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of other Site Managers.
- Participate in site assessments, conduct pretrial site assessment visits and/or participate to study feasibility assessments, providing recommendations from local area about site/investigator selection in collaboration with the trial team.
- Act as primary contact for assigned sites for specific ED&CP trials and work closely with TM and/or IDMM and trial central team regarding study progress and issue resolution.
- Attend/participate in investigator meetings as needed.
- Execute activities within site initiation and startup, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
- Implementation of Analytical Risk Based Monitoring (ARBM) model at the site level when applicable. Monitor study progress at site using study specific systems and available reports/dashboards.
- Ensure site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site and sponsor level.
- Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Ensure site study supplies (such as NonIP, lab kits, etc.) are adequate for trial conduct.
- In collaboration with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS), ensure that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensure clinical drug supplies are appropriately inventoried accounted and returned as applicable, including maintenance of accurate and complete documentation.
- Ensure site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM and/or IDMM when needed.
- Ensure accuracy, validity and completeness of data collected at trial sites. Ensure appropriate measures are in place for maintenance of the blind when applicable.
- Ensure 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. Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.
- Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.
- Fully document trial related activities with respect to study monitoring. Write visit reports and address followup letters to investigators within procedural timelines. Document and escalate major deviations and issues to appropriate stakeholders. Ensure timely corrective actions are completed and documented.
- Review investigator site File for completeness and ensure archiving retention requirements, including storage in a secure area at all times.
- Collaborate with TM for documenting and communicating site/study progress and issues to trial central team.
- Comply with relevant training requirements. Act as local expert in assigned protocols. Develop sufficient Therapeutic Area (TA) and early development knowledge to support roles and responsibilities. Work across TAs dependent upon ED&CP business needs.
- Work closely with TM and/or IDMM to ensure Corrective and Preventive Actions (CAPAs) are completed for QA site audits or inspection and for quality issues identified at the site during routine monitoring and other visit types (e.g. OnSite Quality Monitoring Visit (OSQMV)).
- Prepare 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.
- May participate in the Health Authority (HA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate.
- 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, other site staff and key contacts in ED&CP.
- May be assigned as a coach and mentor to less experienced Site Managers (SMs), Independent Drug Monitors (IDMs) as needed and may perform accompanied site visits as delegated by Functional Manager (FM).
- A minimum of an Associate’s degree or completion of a Nursing Program (LPN) is required. A Bachelor’s degree in Health, Science or Nursing (RN) is preferred.
- A minimum of 2 years of clinical trial monitoring experience or equivalent is required.
- Clinical research monitoring experience in the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolism, Infectious Diseases, Vaccines.
- Experience in a Phase 0, Phase I or Phase Ib trial setting is preferred.
- Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
- Strong computer skills in appropriate software applications and related clinical systems required.
- Must have strong written and oral communication skills.
- The ability to work at a fast pace within small exploratory international study teams in a fast-changing environment is required.
- The ability to work on multiple trials in parallel in different disease areas required.
- Willingness to travel 70%, approximately 3-4 days per week, with overnight stays (2-3 nights on average), is required.
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
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.
United States-New Jersey-Raritan-920 US Highway 202
North America-United States
Janssen Research & Development, LLC (6084)