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.
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.
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.
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.
Manage all aspects of clinical trials from start-up through close-out, ensuring timelines, costs, and quality metrics are met.
Oversee vendor/CRO selection and management, study contracting, budgeting, and forecasting.
Lead study-related activities including protocol preparation, investigator selection, and training, and collaborate with cross-functional teams.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.
Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.
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.
Accountable for leading assigned clinical research activities and partnering with stakeholders on study design.
Conducts on-site and remote site visits, including qualification, initiation, monitoring, and close-out.
Tracks study progress, manages budgets, and mentors junior clinical study managers.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. With over 25 years of experience, the company fosters an inclusive and diverse team culture where employees are empowered to do their best work.
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.
Manage and deliver full clinical site monitoring services for complex multinational projects, ensuring compliance with SOPs, study guidelines, and GCP best practices.
Act as Lead CRA, serving as primary liaison between CRAs and project teams, and participate in development of monitoring plans, protocols, and tools.
Identify and recruit site investigators, oversee investigational site monitoring, and ensure site staff are compliant with training requirements.
Alimentiv is a clinical research organization providing monitoring and site management services for clinical trials. They are a full-time, permanent employer with a focus on building collaborative relationships and maintaining high standards in clinical study delivery.
Serve as primary point-of-contact and escalation point for clients, coordinating all functional services to meet timelines and budget.
Manage the study budget, financial health, and project profitability, ensuring compliance and accurate forecasting.
Develop robust project plans with risk management, maintain quality oversight, and lead internal and client meetings.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences, focusing on Oncology and Rare Disease. The company has an operational scale and expertise to bring life-changing therapies to patients.
Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.
Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.
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.
Own and shape a regional start-up function, building scalable systems and playbooks for site activation across Central/Eastern Europe and Georgia.
Drive site identification, feasibility, and readiness from CDA through activation, collaborating with sites, CROs, and sponsors.
Monitor cycle times and use data to proactively identify bottlenecks and improve activation timelines.
Iterative Health is a healthcare technology and services company that accelerates clinical research to transform patient outcomes, specializing in gastrointestinal, hepatology, obesity, and cardiology. With 250+ employees worldwide, the company fosters a collaborative, low-ego culture focused on high ownership and accountability.
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.
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.