Description de l'offre
Requisition ID: 1805699674W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
Location: Budapest, Hungary
Full-time unlimited contract
A Site Manager (SM) serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), 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 Site Manager 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. May contribute to process improvement and training.
· Acts as primary local company contact for assigned sites for specific trials.
· May participate in site feasibility and/or pre-trial site assessment visits
· Attends/participates in investigator meetings as needed.
· Responsible for executing 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. Responsible for the implementation 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.
· Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
· Ensures site study supplies (such as Non-Investigational Product (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 for the appropriate destruction of clinical supplies.
· Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs.
· Reviews study files for completeness and ensures archiving retention requirements are met, 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.
· Works 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).
· Prepares trial sites for close out, conduct final close out visit.
· 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 Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
· May contribute to process improvement and training.
· A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
· A minimum of 1 year of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
· Specific therapeutic area experience may be required depending on the position.
· Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
· Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
· Proficient in speaking and writing the country language and English. Good written and oral communication. We offer:
· An opportunity to be part of a global market leader
· A dynamic and inspiring working environment
· Many opportunities to work on challenging projects and assignments
· Possibilities for further personal as well as professional development
· Motivating financial remuneration
· Other employee benefits
Janssen-Cilag Kft. (8396)
Clinical Trial Administration