Senior Site Manager (1 of 18) - Janssen Therapeutic Areas
Janssen Research & Development, LLC, a member ofJohnson & Johnson's Family of Companies, is recruiting for a Senior Site Manager. 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, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Senior Site Manager (Senior SM) serves as the primary contact point between the Sponsor and the Investigational Site. The Senior SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), 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 SM 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. The Senior SM may contribute to process improvement, training and mentoring of other Site Managers.
- 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. Writes 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 IEC/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 site manager.
- 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.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
- A minimum of an Associate's degree or completion of a Nursing Program (RN) is required. A Bachelor's degree in a Health or Science discipline is preferred.
- A minimum of 2 years of clinical trial monitoring experience is required.
- Clinical research monitoring experience with any of the following Therapeutic Areas is preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
- Experience with Phase II and Phase III Clinical Trials is preferred.
- 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 and related company clinical systems is required.
- Must be proficient in speaking and writing the country language, English.
- Strong written and oral communication is required.
- Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
United States-New Jersey-Raritan
North America-United States
Janssen Research & Development, LLC. (6084)
Clinical Trial Administration
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