Senior Site Manager ED&CP

Position Summary: A Site ManagerII in Early Development & Clinical Pharmacology (ED&CP)serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of complex early development and/or clinical pharmacology studies. A Site Manager II 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), Healthcare compliance (HCC) requirements, applicable regulations and guidelinesfrom start-up through data-base lock.Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subjectrecruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA, Trial Manager (TM) and GlobalTrial leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols. A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers. 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 selectionin 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 perinternal SOPs, other procedural documentsand policies. Responsible for the implementation of ARBM (Analytical Risk Based Monitoring) model at the site level when applicable. Monitors study progress at site using study specific systems and available reports/dashboards. 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 at site and sponsor level. 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 Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS), ensures that clinical drug supplies are appropriately handled, administeredand stored. Ensures 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. Set up plan 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 blind when applicable 11.Ensures that all Adverse Events(AE)/Serious Adverse Events(SAE)/Product Quality Complaints(PQC)are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure 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 fortrial management. 12.Maintains complete, accurate and timely data and essential documents in systems utilized fortrial management. 13.Fully documents trial related activities with respect to study monitoring. Writesvisit reports and address 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, including storage in a secure area at all times. 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. Actsas local expert in assigned protocols. Developssufficient therapeutic area and early development 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, conduct 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 ensure payments are made, if applicable or collaborates with C&G in charge of site payments. 23.Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology. 24.Coordinates site level lessons learned activities. 25.Acts as a subject matter expert in site management practices 26.May be assigned as a coach and mentor to less experienced SMs, as needed and may perform accompanied site visits as delegated by FM 27.May contribute to process improvement and training, as needed 28.May lead and/or participate in special initiatives as assigned, 29.May assumeadditional responsibilities or special initiatives such as“champion role” or “Subject Matter Expert This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. Principal Relationships: Primary Reporting Structure: Reports to Functional Manager (FM). Primary interfaces:FM, CTAs, TMs, SMs, PIPS, SIPS, GTLs, Study Responsible Physicians (SRP), Quality & Compliance Manager/Specialist, Local Safety Officer Other Internal Interfaces:C&Gs, GPLs, TA representatives, Integrated Data Analytics and Reporting (IDAR), Bioresearch Quality and Compliance (BRQC), ED&CP Head/US ED&CP Head, ED&CP Business Operations & Quality Leader and others as required External Interfaces: Investigational Site Staff and others as required Qualifications Education and Experience Requirements: A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field(or equivalent experience) is required. A minimum of 3 years 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. Experience in monitoring ED&CP studies is preferred. Specific therapeutic area experience/knowledge may be required. Strong knowledge of ICH-GCP, company standard operating procedures, 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/regular overnight stay away from home depending on the region. Proficient in speaking and writing the country language and English. Good written and oral communication skills. Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment. Ability to work on multiple trials in parallel in different disease areas. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we in Spain are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Primary Location Spain-Community of Madrid-Madrid- Organization Janssen-Cilag S.A. (formerly Janssen Sp) (7300) Job Function R&D Requisition ID 2206017078W