Janssen Research & Development LLC., a member of the J&J family of companies is recruiting for a Specialist, Site Manager - Oncology, to be located regionally based throughout 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
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A Specialist, Site Manager - Oncology is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. A Specialist, Site Manager 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), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. 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.
- The Specialist, Site Manager will be a next level role that will require strong leadership, process initiative, influencing and mentoring skills.
- May assume additional responsibilities or special initiatives such as “Champion” or “Therapeutic Area Expert”.
- Participates 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
- Acts as primary local company contact for assigned sites for specific trials.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
- 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.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arranges the appropriate destruction of clinical supplies
- Ensures site staff complete the data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- Ensures 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.
- Maintains 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 documents trial related activities in particular monitoring. Writes visit reports and uploads 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 his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders.
- .Follows the corresponding Monitoring Guidelines for each assigned trial.
- Reviews TCF for completeness and ensures archiving retention requirements, 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.
- Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
- Works 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…,OSQMV.
- Prepares trial sites for close out, conduct final close out visit.
- Negotiates investigator budgets at site level, if applicable.
- Tracks costs at site level and ensure payments are made, if applicable.
- Establishes and maintains 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.
- Acts as an expert in site management practices.
- Usually assigned as a coach and mentor to less experienced site managers.
- Contributes to process improvement and training.
- Leads and/or participates in special initiatives as assigned.
- A minimum of a BA/BS degree is required OR appropriate clinical trials experience may be considered.
- A minimum of 5 or more years of clinical trial monitoring experience is required.
- Clinical research monitoring experience in the ONCOLOGY therapeutic area is Required.
- 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 is required for this level.
- Strong basic computer skills and experience in clinical systems is preferred.
- Proficient in speaking and writing the country language, English, and good written and oral communication skills is required.
- This position can be located regionally based.
- Willingness to travel, 50% or more, 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 also required.
#HEMAONCO Primary Location
United States-New Jersey-RaritanOther Locations
North America-United States-Washington-Seattle, North America-United States-New York-New York, North America-United StatesOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial Administration
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