Perform in-house and remote monitoring activities for clinical trials, ensuring compliance with regulatory requirements and study protocols.
Support study start-up, site selection, and document tracking while assisting CRAs with on-site and remote monitoring.
Communicate with investigative sites to resolve queries and maintain study tracking tools for deviations, SAEs, and data discrepancies.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. The environment is collaborative, international, and focused on improving patient outcomes through high-quality research.
Act as a strategic partner for key customers, leading governance, growth initiatives, financial performance, and cross-functional collaboration.
Lead and oversee global, multiregional, or complex regional Clinical FSP partnerships, ensuring alignment with contractual agreements and strategic priorities.
Provide executive oversight for clinical FSP delivery, ensuring quality, timelines, key performance indicators, and contractual commitments are achieved.
The employer is a global clinical research organization that partners with pharmaceutical and biotech companies to deliver clinical trials. They are a large, established company with a culture focused on innovation, collaboration, and advancing healthcare worldwide.
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.
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.
Manage global clinical trial operations, ensuring adherence to timelines, budget, and quality standards.
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
Build and manage strong relationships with trial investigators and stakeholders, ensuring regulatory compliance.
ICON is a global healthcare intelligence and clinical research organization that helps bring new medicines and treatments to patients faster. It is a values-driven company with a focus on integrity, collaboration, agility, and inclusion, employing a diverse global workforce.
Provide physician-level medical oversight for early-phase clinical trials, ensuring participant safety through screening, eligibility review, and real-time clinical decision-making.
Participate in Safety Review Committee meetings and dose-escalation decisions for first-in-human and ascending dose studies.
Review study protocols, informed consent forms, and safety monitoring plans, and serve as medical liaison during audits and inspections.
Celerion is a Contract Research Organization (CRO) specializing in Phase I and early-phase clinical trials, including first-in-human studies. They partner with pharmaceutical and biotechnology sponsors to advance new therapies, and emphasize integrity, trust, teamwork, and respect as core values.
Lead the development and optimization of clinical data systems, driving data standardization and building scalable validation frameworks.
Architect high-performance databases and ETL pipelines, integrating data from diverse clinical systems across global trials.
Serve as a strategic liaison between Biostatistics, Clinical Operations, and Regulatory Affairs to translate clinical requirements into technical solutions.
Precision Medicine Group is a specialized life sciences company that accelerates the development and delivery of precision medicine. It has a global workforce and fosters a collaborative, compliance-oriented culture focused on innovation and regulatory excellence.
Lead pharmacovigilance strategies and safety signal detection for Apogee's pipeline.
Collaborate with cross-functional teams to ensure high-quality safety data for regulatory submissions.
Provide medical oversight of safety data and contribute to benefit-risk assessments.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.
Conduct inbound and outbound calls to prospective clinical trial participants and perform prescreening interviews.
Educate participants about clinical research and schedule eligible candidates for screening appointments.
Maintain accurate documentation and meet productivity and quality metrics in a remote environment.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate with a collaborative international team and focus on efficient, fair hiring processes.