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Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
SITE MANAGER Location: Budapest Contract: full-time, permanent contract A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site. A Site Manager I 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 I 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. The responsibilities & the impact YOU will have: 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. Responsible 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. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. 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. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures accuracy, validity and completeness of data collected at trial sites Ensures 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. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management. Fully documents 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. 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. Attends regularly scheduled team meetings and trainings. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. 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. Qualifications We would love to hear from YOU, if you have/are: 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 are not required. 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. This is what awaits YOU at J&J: 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. Many employees benefits: 5 weeks of vacation, home office, flexible working hours, sick days Meal vouchers, Cafeteria, referral award, life and accident insurance, MultiSport card Contribution for: Prague public transportation, language study, illness leave, pension contribution, Refreshment in the workplace, company gym, free sports activities, corporate events The benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. 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, or national origin and will not be discriminated against on the basis of disability. Primary Location Hungary-Budapest-Budapest- Organization Janssen-Cilag Kft. (8396) Job Function R&D Requisition ID 2105994289W
Child care benefits
Short term disability