Sr Clinical Trial Manager (Sponsor dedicated) - BA, Argentina with two times per week in client[...]

Sr Clinical Trial Manager (Sponsor dedicated) – BA, Argentina

Chiefly responsible for site management oversight, clinical monitoring, and central monitoring deliverables, ensuring protocol, GCP, and regulatory compliance while safeguarding patient safety and data integrity. Acts as the primary escalation point for investigator site staff and collaborates with cross‑functional teams to meet study milestones and maintain high quality clinical operations, with a focus on risk‑based monitoring and inspection readiness.

Job Responsibilities

• Provide site management oversight, including monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity.
• Oversee site interactions from activation through closeout, including patient recruitment and investigator payments.
• Identify critical data and process risks, complete Risk Assessment and Categorization Tool (RACT) and propose mitigation strategies.
• Review study scope, budget, and protocol content, ensuring compliance with contractual obligations.
• Use operational data and metrics to identify risks to deliverables; report escalations to the project manager.
• Participate in key meetings (e.g., Kick‑Off Meeting) and present risk mitigations.
• Serve as the escalation point for site staff and may interact with site personnel in person or by phone.
• Coordinate with functional leaders (Study Start‑Up, Patient Recruitment, Data Management) to align delivery handoffs and meet site activation, enrollment, and database lock targets.
• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan; oversee system setup (CTMS, dashboards, etc.) and user acceptance testing.
• Coordinate training for the study team on protocols, CRF completion, dashboards, SOPs, and timelines.
• Manage resource allocation for CRAs and Central Monitors, assign site assignments, and monitor team conduct and risks.
• Maintain visibility of progress using approved systems and tracking tools.
• Review dashboards and clinical trial systems (CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, monitoring dashboards) to ensure timely operational execution.
• Understand monitoring strategy; participate in risk assessment plan development and ensure team compliance with CMP/SMP and risk plans.
• Ensure quality of monitoring documentation and adherence to delivery deadlines.
• Provide status updates and risk reports to clients, project management, and leadership; offer solutions to protocol execution obstacles.
• Demonstrate cross‑functional understanding (data management, study start‑up, patient recruitment, medical monitoring, pharmacovigilance, QA) and support inspection readiness.
• Assess site and study‑level training compliance, emerging risks, and develop corrective action plans; support data cut and lock deadlines.
• Offer performance feedback to line managers on staff strengths and development areas.
• Possibly manage larger, complex trials or mentor a team of CTMs across multiple projects.

Qualifications

• Bachelor’s degree, RN, or equivalent combination of education, training, and experience.
• Proven leadership of multidisciplinary teams to achieve project milestones.
• Experience working in an international environment.
• Expertise in site management and monitoring (clinical or central).
• Experience with risk‑based monitoring preferred.
• Understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
• Microsoft Office proficiency and strong computer skills.
• Strong conflict resolution and problem‑solving skills.
• Ability to apply risk management to mitigate threats to successful conduct of clinical research projects.
• Critical thinking to determine causes and solutions for issues.
• Moderate travel (approximately 20%) may be required.

About the Role

Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization’s facilities. They collaborate with principal investigators, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plan logistics and resource usage. They track study progress in alignment with project milestones, client deliverables, and budget, and comply with global and regional regulations.

The role has substantial impact, including strategic vision and tactical direction, directly affecting departmental results. Hands‑on management of processes, policies, and performance of both direct and indirect reports is expected, with direct operational results derived from effectively managing team performance and project execution. Knowledge in scientific, technology, or professional disciplines and a practical understanding of project management in the clinical research context are essential.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, or responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company will determine what constitutes as equivalent to the qualifications described above. This information complies with all relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act, and outlines the Company’s commitment to reasonable accommodations for qualified individuals with disabilities.

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