Johnson & Johnson Careers
Senior Site Manager (Global Clinical Operations)
Requisition ID: 1805661495W
- 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, 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 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.
- May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
- 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 contribute to process improvement and training
Johnson & Johnson Sihhi Malzeme Ltd. (7347)
Klinik Arastirma Yönetimi