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.
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.
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.
Conduct quality control reviews of participant visits and source documentation in the CRIO eSource system to ensure compliance with GCP, ALCOA principles, and client standards.
Identify missing documentation, inconsistencies, protocol deviations, and transcription errors, and document findings in tracking systems.
Collaborate with site personnel to communicate findings, support corrective actions, and contribute to continuous improvement initiatives.
UniTriTeam is a women-owned global workforce solutions organization specializing in clinical research operations, technology, and strategic staffing support. The team is collaborative, accountable, and committed to delivering excellence and integrity.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Manage and oversee all clinical aspects of trials across multiple countries, ensuring timeline adherence, quality, and scope.
Lead CRAs and collaborate with cross-functional teams to achieve high client satisfaction and smooth trial operations.
Identify risks, develop creative action plans, and maintain focus on study priorities through effective communication.
Precision for Medicine is a precision medicine CRO that combines novel trial designs, advanced biomarker analytics, and deep oncology expertise to accelerate drug development. The company fosters a dynamic, high-energy culture and values dedicated professionals who thrive in challenging environments.
Lead and mentor a high-performing team of Clinical Research Associates, ensuring operational excellence and efficient resource utilization.
Manage hiring, onboarding, performance management, and professional development activities for CRA staff.
Collaborate with Project Managers and cross-functional teams to support successful delivery of clinical trials.
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications.
Manage a team of 15-17 Study Management Associates (SMAs) to deliver best-in-class study execution.
Drive performance management, mentoring, and professional development for direct reports.
Support resource management, adherence to regulations, and continuous process improvements.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates across several therapeutic areas including immunology, oncology, and neuroscience, with a significant global presence and a culture focused on innovation and impact.
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.
Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.
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.
Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.
Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.
Develop, mentor, coach and manage CTMs to progress their skillset per quality standards.
Collaborate with management to enhance CTM expectations and procedures for quality and efficiency.
Ensure CTMs have proper resources and training to deliver high-quality study conduct.
Precision for Medicine is a clinical research organization (CRO) that provides clinical trial management services. The company employs a large team of clinical research professionals and emphasizes quality and collaboration.
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.
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.
Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate all necessary activities to set up and monitor a study, including investigator identification, regulatory submissions, and pre-study/initiation visits.
Identify potential study risks, propose solutions, and handle conflict using resolution strategies while maintaining quality and attention to detail.
Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational expertise, and biomarker analytics to advance oncology and rare disease treatments. The company fosters a culture with high CRA retention, small team influence, and a focus on work/life balance.
Provide leadership and high-level technical support for research compliance, including reviewing human subjects research submissions and non-research determinations.
Support project teams with data management plans and ensure compliant closeout of learning activities.
Collaborate with the IRBhelp team to ensure timely review and feedback on submissions.
Jhpiego is a nonprofit global health organization affiliated with Johns Hopkins University, focused on improving the health of women and families. With a global presence, it operates in challenging environments across Africa, Asia, and Latin America, emphasizing research compliance and program learning.
Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.