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 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.
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 study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
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. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
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.
Manage and develop the clinical field sales team within the region.
Expand clinical usage of the da Vinci system in existing accounts and train new surgeons.
Lead system installations, prospect for new installations, and collaborate with training and marketing.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, with technologies like the da Vinci surgical system and Ion. The company is a team of engineers, clinicians, and innovators united to make surgery smarter, safer, and more human, with a collaborative and innovative culture.
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.
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.
Independently manages the study start up activities for multi-center, US and/or global based studies.
Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the immune system, and are committed to continuous innovation in cell therapy.
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.
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.
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.
Hire, train, and develop the clinical field sales team in the assigned region.
Manage ION system program launches and expand procedure usage across existing accounts.
Drive training, KOL development, and communication of product updates to the clinical sales team.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, with technologies like the da Vinci system and Ion. It is a team of engineers, clinicians, and innovators making surgery smarter, safer, and more human.
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.
Manage and develop a clinical field sales team to drive adoption and utilization of the da Vinci surgical system.
Develop sales strategies, train surgeons, and expand usage across existing and new accounts.
Lead installation processes, market new technologies, and collaborate with training and marketing departments.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for technologies like the da Vinci surgical system. With nearly 30 years of innovation, the company employs a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human.
Lead clinical trial strategies and evidence-generation plans supporting global regulatory submissions.
Design and oversee clinical protocols, claims, and evidence strategies in collaboration with internal and external stakeholders.
Serve as a scientific liaison with regulatory authorities and mentor junior scientists to drive clinical excellence.
The company develops diagnostic products for the US and EU markets, focusing on generating robust clinical evidence for regulatory submissions. It maintains a remote-first culture with a collaborative, cross-functional environment and opportunities for scientific leadership.