Clinical Trial Manager (LATAM)

About the Role

This is an exciting, high-impact opportunity based in Mexico to build and lead the expanding clinical operations across Latin America, supporting rapid growth in Mexico, Brazil, Argentina, Colombia, Chile, and Peru. As the clinical lead, you will 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 will shape country-level recruitment strategies, lead feasibility and site start-up, guide monitoring and quality strategies, and mentor CRAs and partners as the regional team scales.

Career Growth Opportunities

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.

Essential Functions

• Serve as the primary clinical point of contact with the client.
• Collaborate with the Project Manager (PM) on monthly invoicing and variance management of the 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 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 lists from key stakeholders and drive the site feasibility process.
• Identify potential risks to enrollment targets based on feasibility analysis and site commitment.
• Develop and finalize the country recruitment/retention strategy.
• Develop timely and effective communication and good working relationships with investigators and study teams to ensure effective and timely feasibility, site start-up, enrollment, maintenance, and close-out procedures.
• Lead internal clinical team meetings and set expectations for the clinical team of CRAs and CTAs.
• Address CRA and site questions and maintains a Frequently Asked Questions (FAQ) log.
• Support planning and conducting investigator meetings.
• Review and/or approve IP release packages.
• Oversee, support, and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments.
• Develop clinical monitoring strategies to ensure study timelines are met and quality deliverables are achieved.
• Generate and utilize metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure the study is conducted per plan and communicate issues to the PM and CRAs.
• Responsible for eTMF implementation and management.
• Collaborate with PM, CRAs, and QA to develop Corrective and Preventative Action Plans (CAPA) and is accountable for implementation and timely closure.
• Assist sites, internal staff, and CRAs with preparation for GCP audits.
• Work closely with the 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 as needed when a cross-functional PM is not assigned.
• Support business development and marketing activities as appropriate.
• May negotiate site budgets and investigator contracts with support from legal and/or site contracts group.
• May review site visit reports and ensures monitoring is executed per the monitoring plan.
• May be responsible for the management of clinical vendors (e.g., labs, IP, patient diary, home health care) in conjunction with the PM.
• May perform clinical data review of patient profiles, data listings, and summary tables, including query generation.
• May have line management responsibilities.
• Perform other duties as assigned by management.

Qualifications

Minimum Required:

• Bachelor’s degree or equivalent combination of education/experience in a science or health-related field. Advanced degree preferred.
• Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
• Professional working proficiency in English required.

Preferred:

• Advanced degree.

Other Required:

• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint).
• Excellent communication and interpersonal skills.
• Excellent organizational skills, attention to detail, and a customer service demeanor.
• Ability to travel domestically and internationally, including overnight stays.

Competencies

• Mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance.
• Working knowledge of clinical management techniques and tools.
• Direct work experience in a cross-functional environment.
• Proven experience in functional management, including delegation and fostering cohesive team dynamics.
• Proven experience in planning, risk management, and change management.
• High level of integrity and ability to inspire and demand the highest professional and ethical standards.
• Ability to lead and inspire excellence within a team.
• Ability to create an environment where employees have a sense of ownership, leading to increased productivity and efficiency.
• Results-oriented, accountable, motivated, and flexible.
• Excellent time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills.
• Excellent presentation, verbal, and written communication skills.
• In-depth proven experience in pharmaceutical and/or device research.
• Demonstrated successful independent negotiation and conflict management strategies.

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Equal Opportunity Employer

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

Reasonable Accommodation

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process, you may contact myHR@precisionmedicinegrp.com for an alternative method of applying.

Recruitment Fraud Warning

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