Site Manager (Clinical Research Associate)

We are looking for a Site Manager, located Turkey, to serve as the primary contact point between the Sponsor and the Investigational Site. As Site Manager, you will be 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.

Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure... and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring ground breaking science and the most creative minds in the industry together to think differently about diseases. We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

Principal Responsibilities:
• Acting as primary local company contact for assigned sites for specific trials across multiple therapeutic areas.
• Site feasibility and/or pre-trial site assessment visits
• Attending/participating 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 an analytical risk-based monitoring model at the site level and to work with the 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 for close collaboration with LTM and central study team for the activities during the site activation phase in order to speed up the process and activate the site in the shortest possible timeframe.
• Participating in site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
• Ensuring site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
• Ensuring 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.
• Ensuring site staff complete data entry and resolve queries within expected timelines.
• Ensuring accurate, valid and complete data collection 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 activities, in particular monitoring. Writes visit reports and follow-up letters in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate partners.
• Reviews study files for completeness and ensure archiving retention requirements are met, including storage in a secure area at all times.
• Collaborates with LTM for documenting and communicating site/study progress/issues to the trial central team.
• Attends regularly scheduled team meetings and trainings.
• Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified on site during routine monitoring and other visit types, e.g. On-Site Quality Monitoring Visit (OSQMV).
• Prepares trial sites for closeout, conduct final closeout visit!
• Tracking site costs and ensure payments are made, if applicable.
• May participate to process improvement and training
İstanbul Türkiye

Salary Criteria