Senior Site Manager

Overview

Senior Site Manager (CRA - Monitor de Pesquisa Clinica II) at Johnson & Johnson Innovative Medicine, São Paulo, Brazil.

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Purpose: A Senior, Site Manager is a mid-level site management role with typically 3-5 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. Responsibilities may include assisting with site selection, site qualification assessment, subject 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 Trial Delivery Leader (TDL) to ensure overall site management while performing trial related activities for assigned protocols. A Senior, Site Manager may contribute to process improvement, training and mentoring of other Site Managers. A Senior, Site Manager is generally expected to be able to operate independently with little or limited supervision.

• Acts as primary local company contact for assigned sites for specific trials.
• May participate in site feasibility and/or Site Qualification Visit.
• Attends/participates in investigator meetings as needed, may help prepare meeting materials and may be required to present at the IM.
• Executes activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management and close-out according to SOPs, Work Instructions and policies. Implements analytical risk-based monitoring at the site level and collaborates with the site to resolve issues found during monitoring visits. Works independently with little or no supervision.
• Ensures site staff are trained and training records are complete. Supports site activation with LTM to speed up activation timelines. May help address challenges at other sites in the country.
• Contributes to site-level recruitment strategy and contingency planning in partnership with other functional areas.
• Ensures site study supplies are adequate for trial conduct.
• Ensures appropriate handling, storage and inventory of clinical drug supplies and returns; arranges destruction as needed.
• Manages data entry, query resolution and data quality at trial sites.
• Maintains data integrity and essential documents in trial management systems.
• Documents trial-related activities, writes visit reports and follow-up letters per SOPs; communicates status and issues to stakeholders.
• Reviews study files for completeness and ensures archiving retention requirements are met.
• Collaborates with LTM for site/study progress and issues reporting to the trial central team.
• Attends team meetings and trainings; complies with training requirements and maintains therapeutic knowledge for assigned protocols.
• Works with LTM to ensure CAPA is completed for QA site audits and quality issues; may oversee audit/inspection prep for junior staff.
• Prepares trial sites for close-out and conducts final close-out visit.
• Tracks site-level costs and ensures payments are processed if applicable.
• Establishes and maintains good working relationships with investigators, trial staff and other site personnel.
• May participate in Health Authority and IEC/IRB submission and notification processes as required.
• Acts as a point of contact in site management practices and may provide insights and input.
• On occasion may coach and mentor less experienced site managers and contribute to process improvements and trainings.
• May lead or participate in special initiatives as assigned and may assume additional responsibilities such as Champion or Subject Matter Expert.

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related field (or equivalent) is required.
• Minimum 2 years of clinical trial monitoring experience required; 3-5 years preferred. Other relevant experience may be considered.
• Specific therapeutic area experience may be required depending on the position.
• Strong knowledge of GCP, SOPs, local regulations, protocols and monitoring guidelines.
• Strong IT skills; willingness to travel with possible overnight stays.
• Fluent in country language and English; strong written and oral communication.
• Ability to manage multiple trials in parallel; demonstrated capability to deliver clinical trials and engage with sites effectively; strong problem-solving skills.