Janssen Research & Development LLC., a member of the J&J Family of Companies is recruiting for a Specialist, Site Manager, to be located regionally based throughout the United States, preferably in the Northeast or Midwest.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Specialist, Site Manager will oversee Trial Coordination and Site Management and serve as primary contact point between the sponsor and the investigational site. This individual will be 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), applicable regulations and guidelines from start-up through data-base lock. Responsibilities will include: site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. The Specialist,, Site Manager will partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. Contribute to process improvement, training and mentoring of other Site Managers.
- Provide strong leadership, process initiative, influencing and mentoring skills.
- May assume additional responsibilities or special initiatives such as “Champion” or “Therapeutic Area Expert”.
- Participate in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
- Act as primary local company contact for assigned sites for specific trials.
- Attend/participate in investigator meetings as needed.
- Execute activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
- 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 Non-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 the appropriate destruction of clinical supplies
- Ensure site staff complete the data entry and resolve queries within expected timelines.
- Ensure accuracy, validity and completeness of data collected at trial sites
- Ensure that all AEs/SAEs/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 systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints.
- Fully document trial related activities in particular monitoring. Write visit reports and upload into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and their team with 15 working days. Promptly communicate relevant status information and issues to appropriate stakeholders.
- .Follow the corresponding Monitoring Guidelines for each assigned trial.
- Review TCF for completeness and ensures archiving retention requirements, 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. Develop therapeutic knowledge sufficient to support roles and responsibilities.
- Work closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types (e.g. SQMV).
- Prepare trial sites for close out, conduct final close out visit.
- Negotiate investigator budgets at site level, if applicable.
- Track costs at site level and ensure payments are made, if applicable.
- Establish and maintain good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.
- May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
- Act as a point of contact in site management practices.
- Act as an expert in site management practices.
- Usually assigned as a coach and mentor to less experienced site managers.
- Contribute to process improvement and training.
- Lead and/or participate in special initiatives as assigned.
- A minimum of a Bachelor's degree OR appropriate clinical trial experience is required.
- A minimum of 6 years of clinical trial monitoring experience is required.
- Clinical research monitoring experience in Neuroscience or Immunology is preferred.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures, including monitoring guidelines, required.
- Strong leadership, process initiative, influencing and mentoring skills required.
- Strong basic computer skills and experience in clinical systems preferred.
- Must be proficient in speaking and writing the country language, English.
- Must have good written and oral communication skills.
- Willingness to travel 50%, approximately 2-3 days per week, with overnight stay, is required.
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
United States-New Jersey-RaritanOther Locations
North America-United StatesOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial Administration
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