Clinical Trial Manager; LATAM

We’re hiring a Clinical Trial Manager to help build and lead our expanding clinical operations across Latin America. This is an exciting, high‑impact opportunity based in Mexico, supporting rapid growth across Mexico, Brazil, Argentina, Colombia, Chile, and Peru.

As the clinical lead, you’ll own the planning, execution, and oversight of clinical studies, serving as the primary client contact and ensuring delivery in compliance with protocol, SOPs, ICH‑GCP, and regulatory requirements. You’ll shape country‑level recruitment strategies, lead feasibility and site start‑up, guide monitoring and quality strategies, and mentor CRAs and partners as we scale a new regional team.

This role offers significant career growth, including opportunities to build teams, define processes, influence culture, and step into broader leadership and project management responsibilities as the region grows.

• Primary clinical point of contact with the client
• Collaborate with PM on monthly invoicing and variance management of clinical budget
• Develop study related clinical documents (e.g., clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
• Identify and develop training needs for CRAs and third‑party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick‑off meetings
• Generate potential site list from key stakeholders and drive site feasibility process
• Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
• Develop and finalize the country recruitment/retention strategy
• Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start‑up, enrollment, maintenance and close‑out procedures
• Lead internal clinical team meetings and set expectations for clinical team of CRAs and CTAs
• Address all CRA and site questions and maintain Frequently Asked Question (FAQ) log as appropriate
• Support in planning and conducting investigator meetings
• Review and/or approve of IP release packages
• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
• Generate and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicate issues to PM and CRAs as appropriate
• Responsible for eTMF implementation and management
• Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and be accountable for implementation and timely closure
• Assist sites, internal staff and CRAs with the preparation for GCP audits
• Work closely with PM for project‑specific resourcing issues
• Escalate pertinent CRA performance and site compliance issues when necessary
• Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
• Manage processes for investigational product (IP) including drug accountability and reconciliation
• Assume project‑management responsibility when a cross‑functional PM is not assigned to a given program
• Support business development and marketing activities as appropriate
• Negotiate site budget and investigator contract with support from the legal department and/or site contracts group
• Review site visit reports and ensure monitoring (i.e., scheduling and scope) is executed per monitoring plan
• Manage clinical vendors (e.g., labs, IP, patient diary, home health care) in conjunction with PM
• Perform clinical data review of patient profiles, data listings and summary tables, including query generation
• Have line management responsibilities
• Perform other duties as assigned by management

• Bachelor’s degree or equivalent combination of education/experience in science or health‑related field. Advanced degree preferred.
• Minimum of 7 years of clinical…