Manage TMF operations activities for multiple complex studies or sponsor portfolios.
Oversee Trial Master File quality control including planning, tracking, and reporting.
Support regulatory inspections and sponsor audits while collaborating with cross-functional teams.
This is a global clinical research environment focused on ensuring accuracy, compliance, and quality of essential trial documentation. The company operates with a collaborative international team and values inclusion, professional growth, and purpose-driven healthcare work.
Oversee Trial Master File (TMF) activities including document review, quality checks, and study-level engagement to ensure regulatory compliance.
Manage a team of Documents Specialists, Quality Review Specialists, and TMF Leads, providing training, performance management, and support.
Collaborate with leadership to drive process improvements and ensure efficient records management across clinical programs.
Precision Medicine Group is a contract research organization providing clinical research services. The company is expanding across Latin America and fosters a collaborative, quality-focused culture.
Ensure timely review, processing, and quality of Trial Master Files (TMF) according to GCP and SOPs.
Create and execute study TMF plans, manage document indexing, and communicate changes to project teams.
Monitor TMF health, identify risks, and support audits and inspections for compliance.
Precision Medicine Group is a global contract research organization providing clinical trial support and precision medicine services. The company values professionalism, collaboration, and quality, with a focus on maintaining inspection-ready trial master files.
Acts as primary site contact and liaison for study management issues, ensuring compliance with ICH-GCP and regulatory requirements.
Manages essential document collection, maintenance, and TMF organization, and coordinates investigator recruitment activities.
Assists with data review, EDC entry, and supports offsite central monitoring and study supply management.
Precision Medicine Group is a clinical research organization providing services to pharmaceutical and biotech companies. The company has a global presence and fosters a collaborative culture focused on precision medicine.
Act as primary clinical point of contact with clients and lead planning, execution, and oversight of clinical studies across Latin America.
Develop country-level recruitment strategies, guide monitoring and quality strategies, and mentor CRAs and partners.
Collaborate with project managers on budgets, vendor management, and ensure compliance with ICH-GCP and regulatory requirements.
Precision Medicine Group is a precision medicine company that provides clinical research and commercialization services. The company is an Equal Opportunity Employer with a focus on expanding clinical operations across Latin America.
Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.
AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.
Lead execution of RBQM strategy across complex clinical trials, including risk assessments and monitoring plans.
Partner with cross-functional teams and CROs to identify, track, and mitigate risks proactively.
Ensure compliance with global regulations, drive process improvements, and report KRIs to leadership.
Deciphera is a biopharmaceutical company focused on developing kinase inhibitor therapies for cancer. The company offers a competitive compensation package and promotes a culture of personal and professional growth.