Oversee EMEA clinical trial operations, partnering with CROs and sites to ensure compliance and timely execution.
Lead regional regulatory submission strategies and proactively resolve operational challenges to maintain study timelines.
Mentor junior team members, review data and TMF documentation, and provide regular study updates to stakeholders.
Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing transformative treatments for metabolic diseases. The company fosters a collaborative culture of problem solvers dedicated to bringing bold scientific approaches to patients.
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.
Lead and manage a team of 15-17 Study Management Associates to ensure best-in-class study execution.
Drive performance management, development, and training of direct reports in a global, remote team environment.
Support resource planning and process improvements to meet organizational goals and business continuity.
AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues today and address medical challenges of tomorrow, focusing on therapeutic areas like immunology, oncology, and neuroscience. We are a global biopharmaceutical company with a large workforce and a culture that values integrity, innovation, and community service.
Lead and oversee global Phase 0-4 clinical trials with cross-functional teams from inception to closure.
Manage external vendors, recruitment strategies, and study systems to ensure quality, efficiency, and inspection readiness.
Collaborate with study project managers to drive timelines, budgets, and compliance with ICH/GCP and AbbVie policies.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and Allergan Aesthetics. They are a global, science-driven pharmaceutical company committed to integrity, innovation, and serving the community.
Establish and maintain relationships with investigators, sites, and key opinion leaders to support trial execution.
Gather site feedback and translate it into actionable improvements for study teams.
Contribute to protocol development, site selection, and business development activities.
This role is with a partner company that focuses on clinical research and trial execution. The company operates remotely and values collaboration, inclusion, and professional autonomy.
Manage all clinical aspects of assigned studies across multiple countries, ensuring timeline adherence and quality.
Lead CRAs and support site selection, start-up, enrolment, monitoring, data cleaning, and close-out.
Identify risks to timelines and collaborate with teams to deliver high client satisfaction.
Precision for Medicine is a precision medicine CRO combining novel trial designs, operational experts, and biomarker analytics with a focus on oncology and rare diseases. It encourages high-energy professionals who thrive in dynamic environments.
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.
Lead and coach a team of Clinical Study Operations professionals overseeing device-based clinical trials from feasibility to close-out.
Drive domain-level ClinOps initiatives including process standardization, tooling, and data quality improvements.
Represent ClinOps in business development conversations, feasibility discussions, and Investigator Meetings, ensuring operational readiness.
Beacon Biosignals transforms precision medicine for the brain, offering at-home EEG and diagnostic platforms for neurological, psychiatric, and sleep disorders. They are a remote-first, distributed company with hubs in Boston, New York, and Paris, emphasizing curiosity, sound judgment, and empathy.
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.
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.
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.
Build and maintain excellent client relations to ensure high-quality service.
Work closely with internal teams and third-party partners to support clinical trial materials projects.
Assist in financial management and produce regular status updates for clients.
MEDiSTRAVA is a leader in medical communications, providing targeted solutions across strategy, patient engagement, and clinical trial optimization. They have a dynamic team and offer a friendly, informal working environment with growth opportunities.
Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.
Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.
Lead cross-functional trial teams to execute global clinical trials from start-up to closeout.
Oversee CRO/vendor selection, budget management, and operational risk mitigation.
Ensure compliance with regulations and GCP, and foster team development and mentorship.
Alnylam Pharmaceuticals is a biopharmaceutical company that translates RNA interference (RNAi) into a new class of innovative medicines for rare and prevalent diseases. With a people-first culture and core values of innovation and excellence, Alnylam is a top employer recognized globally.
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.
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.
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.
Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
Support regulatory team in preparing documents for study submissions and participate in feasibility research.
PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization.
Develop, simplify, and maintain Clinical Operations SOPs, work instructions, and process documentation.
Act as senior Clinical Operations SME for audits, inspections, CAPAs, and strategic initiatives.
Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and data sciences. The company has a collaborative culture and supports remote work across Europe.