Lead and facilitate risk management for clinical studies to ensure patient safety and data integrity.
Perform Centralized Monitoring, analyze Key Risk Indicators, and present results to study teams and clients.
Develop study-specific plans, manage targeted SDV and monitoring strategies, and contribute to proposals.
PSI is a leading Contract Research Organization (CRO) delivering quality and on-time clinical research services across various therapeutic indications. It is a stable yet innovative company with almost 30 years of market experience.
Lead project teams to ensure efficient execution of clinical trials.
Manage day-to-day project operations while adhering to timelines and budgets.
Coordinate team activities and resources for optimal project delivery.
Jobgether uses an AI-powered process to ensure applications are reviewed quickly and fairly against the role's core requirements. They identify top-fitting candidates and share this shortlist with the hiring company.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for over 35 trials per year.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates on submission status and regulatory guidance on study development.
Act as the liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments, ensuring all facets of each protocol are compliant.
Emory University is a leading research university that fosters excellence and attracts world-class talent. Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and providing innovative therapies and clinical trials.
Support site initiation, management, and close-out activities.
Ensure trial conduct complies with protocol and regulatory requirements.
Participate in data review and support site readiness.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease by staying true to their values and innovating boldly.
Serve as the primary Medical Monitor for assigned clinical trials.
Lead ongoing clinical data review to ensure integrity, completeness, and scientific validity.
Provide strategic guidance across functions to optimize trial design, recruitment, and execution.
Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. They are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.
Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania, with a culture that emphasizes collaboration and high-quality execution.
Responsible for managing research activities at sites participating in Worldwide’s clinical research projects.
Involved in all stages of the clinical study, including identifying potential sites and performing study start-up activities.
Conduct study initiation visits and ensure compliance with informed consent and reporting potential safety events.
Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates and invents to cure the world’s most persistent diseases. They are a global team of over 3,500+ experts, bright thinkers, dreamers and doers that are changing the way the world experiences CROs.
Work cross functionally to develop partnership strategies for clinical trials and programs.
Provide leadership and oversight on all clinical programs.
Optimize the profitability of the Project Management organization to meet or exceed budget targets.
Precision Medicine Group is a company that works in the clinical trial and program development space. We empower pharmaceutical and life sciences companies to accelerate their drug development, research, and commercialization endeavors.
Coordinate day-to-day clinical trial operations remotely, ensuring compliance with study protocols and regulatory guidelines.
Support and facilitate remote patient visits, including scheduling, documentation, and follow-up.
Maintain accurate and timely data entry in EDC and CTMS systems and manage query resolution.
UniTriTeam is a global leader providing operational, administrative, and technology support to clinical research sites. They take pride in their mission to help advance medicine and make a real impact in healthcare, fostering a collaborative and supportive work environment.
Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials.
Provide support in site recruitment, site initiation, site payments and site close-out.
Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
ImmunityBio, Inc. is a commercial-stage biotechnology company that develops cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system. The company is publicly traded with headquarters in Southern California, offering a collaborative environment with professional development opportunities.
Support the administrative execution of clinical trials, including document formatting, information review, and study status tracking.
Manage study-specific information using databases and tools, and assist in reviewing essential documentation like informed consent forms and study plans.
Coordinate clinical trial logistics such as supplies management, meeting setup, and sample movement between sites and laboratories.
Sumitomo Pharma America is a global pharmaceutical company focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. It has a diverse pipeline and aims to accelerate research to bring novel therapies to patients, operating within a fast-paced, collaborative environment driven by a mission for better healthcare.
Considered as the primary point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs).
Customize site engagement strategy for assigned study (ies) under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
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. They strive to have a remarkable impact on people's lives across several key therapeutic areas. For more information about AbbVie, please visit them at www.abbvie.com.