[Hiring] Senior Site Manager @Johnson & Johnson Innovative Medicine

Role Description

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for the Sr. Site Manager (Sr. CRA - Monitor de Pesquisa Clínica Sr) position. This is a home-based role, with a preference for candidates located in São Paulo. We have 2 positions available.

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.
• Partnering with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and TDL (Trial Delivery Leader) to ensure overall site management.
• Contributing to process improvement, training, and mentoring of other Site Managers.
• Operating independently with little or limited supervision.

Qualifications

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience) is required.
• A minimum of 2 years of clinical trial monitoring experience is required; 3-5 years preferred.
• Specific therapeutic area experience may be required depending on the position and is an added advantage.
• Strong working knowledge of GCP, company SOPs, 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 overnight stay away from home.
• Proficient in speaking and writing the country language and English. Good written and oral communication.
• Ability to work on multiple trials in parallel.
• Demonstrated capability to consistently deliver clinical trials.
• Demonstrated capability to effectively communicate and engage with sites and site personnel.
• Demonstrated problem-solving capability.

Requirements

• 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.
• Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring, site management, and site/study close-out according to SOPs, Work Instructions (WIs), 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.
• Ensures site study supplies are adequate for trial conduct.
• Ensures 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.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures accuracy, validity, and completeness of data collected at trial sites.
• Proactively 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.
• Maintains complete, accurate, and timely data and essential documents in relevant systems utilized for trial management.
• Fully documents trial related activities, particularly monitoring. Writes visit reports and follow-up letters in accordance with the SOPs.
• Reviews study files for completeness and ensures archiving retention requirements are met.
• 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. Acts as local expert in assigned protocols.
• Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits.
• Prepares trial sites for close out, conducts final close out visit.
• Tracks costs at site level and ensures payments are made, if applicable.
• Establishes and maintains good working relationships with internal and external stakeholders.
• May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
• Acts as a point of contact in site management practices.
• May be assigned as a coach and mentor to a less experienced site manager.
• May be required to contribute to process improvement and training.
• Occasionally leads and/or participates in special initiatives as assigned.
• May be required to assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert.

Benefits

• Inclusive work environment.
• Respect for diversity and dignity of employees.