Senior Clinical Trial Manager (LATAM)

OpenKrill; United States; A distancia; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Precision Medicine Group is seeking a Senior Clinical Trial Manager to lead clinical operations across Latin America, focusing on Mexico, Brazil, Argentina, Colombia, Chile and Peru. You’ll own planning, execution, and oversight of studies, serve as primary client contact, and ensure delivery in line with protocol, ICH-GCP, and regulatory requirements.

You’ll develop country recruitment strategies, guide site start-up and monitoring, mentor CRAs and partners, and help build a regional team as

Formación

• Bachelor’s degree or equivalent in science or health-related field; advanced degree preferred.
• Minimum of 7 years of clinical research experience with substantial monitoring exposure.
• Professional working proficiency in English required.

Responsabilidades

• Own planning, execution, and oversight of clinical studies across LATAM.
• Serve as primary client contact and ensure delivery per protocol, SOPs, ICH-GCP, and regulatory requirements.
• Develop country recruitment/retention strategy and lead feasibility and site start-up.

Conocimientos

English proficiency

Communication

Organization

Leadership

Travel

Interpersonal skills

Cross-functional

Negotiation

Problem solving

Educación

Bachelor's degree in science/health

Advanced degree

Herramientas

Microsoft Office

Descripción del empleo

We’re hiring a Senior Clinical Trial Manager to help build and lead our expanding clinical operations across Latin America. This is an exciting, high‑impact opportunity, 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.

Essential functions of the job include but are not limited to:

• 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 sets expectations for clinical team of CRAs and CTAs
• Address all CRA and site questions and maintains 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 utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates 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 is accountable for implementation and timely closure
• Accountable to 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
• Collab... etc.
• ...

Qualifications:

Minimum Required:

• Bachelor’s degree or equivalent combination of education/experience in 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 to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Ability to travel domestically and internationally including overnight stays

Competencies:

• Demonstrates mastery knowledge of ICH‑GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Direct work experience in a cross‑functional environment
• Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics
• Proven experience in planning, risk management and change management
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in 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 communications skills
• In depth proven experience in pharmaceutical and/or device research required
• Demonstrated successful independent negotiation and conflict management strategies

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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.

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 and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].

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Candidates must be legally authorized to work in the country of employment without employer sponsorship.