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We are searching the best talent for Senior Site Manager to be in Buenos Aires, Argentina (remote).
Purpose: The Senior Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. The Sr. Site Manager 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 startup through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Senior 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. The Sr. Site Manager may contribute to process improvement, training and mentoring of other Site Managers.
As the Senior Site Manager, you will:
• Act as primary local company contact for assigned sites for specific trials, may participate in site feasibility and/or pre-trial site assessment visits, and attend/participate in investigator meetings as needed.
• Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management and site/study close-out according to SOPs, Work Instructions and policies. As well as implement analytical risk based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits.
• Ensure 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.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
• Ensure site study supplies are adequate for trial conduct.
• Ensure site staff complete data entry and resolve queries within expected timelines.
• Ensure accuracy, validity and completeness of data collected at trial sites
• Ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
• 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.
• A minimum of a bachelor’s degree is required, preferably in a health or science related field.
• A minimum of four (4) years of experience is required.
• Experience in clinical trials or working as a Site Manager (CRA) is preferred.
• Good knowledge of ICH-GCP, Standard Operating Procedures (SOP), local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines is preferred.
• Strong IT skills in appropriate software and systems is preferred.
• This position may require up to 25% of travel.
• Proficiency in speaking and writing in English (intermediate level) is required.