Associate Site Manager Early Development

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Madrid, Spain Position Summary: An Associate Site Manager Early Development serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of Early Development and/or Clinical Pharmacology (ED&CP) studies. An Associate 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 - Principal Responsibilities: 1. Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team. 2. Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution. 3. Attends/participates in investigator meetings as needed. 4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies. 5. Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed appropriately. 6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. 7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct. 8. In collaboration with Manager Site Investigational Product Specialist (SIPS) and Manager Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered, and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation. 9. Ensures site staff complete the data entry and resolve queries within expected timelines. Sets up plans to improve data entry in collaboration with TM when needed. 10. Ensures accuracy, validity and completeness of data collected at trial sites. Ensures appropriate measures are in place for maintenance of the blinding when applicable. 11. Ensures that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) 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. 12. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management. 13. Fully documents trial related activities with respect to study monitoring. Writes visit reports and addresses follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented. 14. Reviews investigator site file for completeness and ensures archiving retention requirements. 15. Collaborates with TM for documenting and communicating site/study progress and issues to trial central team. 16. Attends regularly scheduled team meetings and trainings. 17. Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and ED&CP knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs. 18. Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV). 19. Prepares trial sites for close out, conducts final close out visit. 20. May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations. 21. May participate in the HA and IEC/IRB submission and notification processes as required/appropriate. 22. Tracks costs at site level and ensures payments are made, if applicable or collaborates with CCS in charge of site payments. 23. Establishes and maintains go