Manage day-to-day clinical trial operations, including CRO/vendor oversight and site management.
Lead cross-functional study teams, develop study documents, and implement risk mitigation strategies.
Ensure high-quality deliverables within timelines and budget, from start-up through close-out.
Ultragenyx is a biopharmaceutical company dedicated to developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture focused on learning and growth, with a global team committed to innovation.
Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
Manages external vendors, recruitment strategies, and cross-functional team coordination.
Maintains inspection readiness and contributes to risk management and process improvement.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.
Lead and oversee global clinical trials from inception to closure, managing cross-functional teams and vendors.
Ensure compliance with ICH/GCP and regulatory standards while driving recruitment and risk management strategies.
Manage study materials, systems (EDC, IRT, CTMS), and provide training to stakeholders.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines in immunology, oncology, neuroscience, and aesthetics. With a global presence, they emphasize integrity, innovation, and community service.
Provides operational leadership for global clinical trials, overseeing the clinical operations team and vendor performance.
Ensures effective study delivery through cross-functional collaboration, proactive risk management, and strong execution oversight.
Manages CROs, vendors, and strategic partners, driving financial accountability and maintaining inspection readiness.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. With multiple global Phase 3 clinical studies, the company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Lead clinical trial execution and operational delivery across internal and external stakeholders from start-up through execution.
Provide oversight of CROs, vendors, and clinical trial partners to ensure quality, compliance, timelines, and budget objectives are achieved.
Serve as the Clinical Operations leader for the team of CTMs, CRAs, and CTAs for each assigned project.
Immatics is a global leader in precision targeting of PRAME for cancer immunotherapy, with a robust clinical pipeline spanning TCR T-cell therapies and TCR bispecifics. The company fosters a collaborative and innovative culture focused on making a meaningful impact on patients.
Oversee global clinical trial execution, including site selection, activation, enrollment, and closeout, while ensuring compliance with GCP and regulatory requirements.
Partner with CROs to drive robust trial management, data monitoring, and patient enrollment strategies, and review study-related plans and documents.
Mentor and guide clinical operations team members, track performance metrics, and ensure inspection readiness across all study phases.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving unmet medical needs through innovative clinical studies. With multiple global Phase 3 trials and offices across the US, UK, and Ireland, the company is committed to a collaborative, people-driven culture.
Serve as primary point-of-contact liaison with clients, providing outstanding customer service and participating in proposal activities and client presentations.
Oversee all aspects of clinical research trials, directing project managers and ensuring consistency across assigned portfolios.
Manage study budgets, financial health, and project plans, including risk management and quality assurance, while leading cross-functional teams.
Precision Medicine Group is a people-focused CRO that combines novel clinical trial designs, industry-leading operational and medical authorities, and advanced biomarker and data analytics solutions, with a passion for rare diseases and oncology. The company fosters a supportive and collaborative environment, promoting work-life balance and team development, with a growing team dedicated to ground-breaking cancer therapies.
Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.
Support operational execution of clinical studies from initial synopsis through final deliverables.
Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
Oversee cross-functional study teams and ensure compliance with regulations and data integrity.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.
Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.
Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.
Manage end-to-end clinical studies ensuring on-time and on-budget delivery with high quality standards.
Lead multifunctional study management teams and serve as primary point of contact for client study teams.
Oversee project planning, resource allocation, and financial management while ensuring regulatory compliance.
Science 37 is a clinical research organization focused on decentralized clinical trials. They value employee well-being and provide an equal opportunity workplace.
Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
Manages vendor selection, oversight, and study-related training, and proactively resolves issues.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.
Serve as the primary Clinical QA point of contact for a Phase 3, global study.
Collaborate with cross-functional groups to support study start-up and execution.
Perform clinical site audits and support inspection readiness.
Priovant is a biopharmaceutical company committed to developing therapies for autoimmune diseases. They have a small, collaborative team with a hands-on culture.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Manage clinical study vendors and ensure deliverables are on time, within budget, and compliant with FDA and ICH/GCP guidelines.
Support CRO collaboration, site start-up, study documentation, and risk mitigation with cross-functional teams.
Leverage AI tools and process improvements to enhance clinical operations productivity and quality.
This biotechnology company focuses on developing innovative oncology therapies. It offers a collaborative, multidisciplinary environment with opportunities to use AI-enabled tools and modern approaches to clinical operations.
Oversee strategic planning and execution of global clinical studies.
Manage internal and external resources, including CROs, to ensure quality and compliance.
Lead cross-functional teams and contribute to trial design and budgeting.
Dianthus Therapeutics is a clinical-stage biotechnology company developing novel therapies for severe autoimmune diseases. The company values a culture centered on core principles and aims to elevate patient care.
Manage global, multi-center clinical research projects in a variety of therapeutic areas.
Deliver projects on time, within budget, and in accordance with high quality standards.
Lead and mentor project teams, and serve as the primary point of contact to clients on all project matters.
PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. They focus on delivering quality and on-time services across a variety of therapeutic indications.
Take your career to the next level and lead challenging global clinical research projects.
Manage the full scope of responsibilities and get hands-on involvement in every aspect of the study.
Work remotely or hybrid while managing multi-functional project teams and client relationships.
PSI is a leading Contract Research Organization with 30 years of experience, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications, and invest in their people's professional development.
Manage global, multi-center clinical research projects in various therapeutic areas.
Deliver projects on time, within budget, and to high quality standards while leading multifunctional teams.
Serve as primary client contact, participate in bid defenses, and ensure compliance with procedures.
PSI is a leading Contract Research Organization with 30 years of experience in the industry, offering a balance between stability and innovation. We focus on delivering quality and timely services across various therapeutic indications, investing in our people's professional development.