Oversee clinical study operations from startup through close-out, ensuring quality and compliance.
Act as primary operational partner to sponsors, project teams, and clinical sites.
Foster a culture of quality by coaching peers on GCP compliance and documentation discipline.
Beacon Biosignals is transforming precision medicine for the brain, offering EEG and cardiopulmonary platforms for clinical development and diagnostics. The company has office hubs in Boston, New York, and Paris, and fosters a first-class remote work culture with a focus on diversity and impact.
Collaborate with project teams and clinical sites to support study startup, training, and device deployment.
Ensure compliance with GCP, ICH guidelines, and regulatory standards while monitoring project progress.
Address operational issues and provide feedback to improve devices and workflows.
Beacon Biosignals is transforming precision medicine for the brain by offering at-home EEG platforms for clinical development and diagnostics. The company fosters a remote-first culture with office hubs in Boston, New York, and Paris, emphasizing asynchronous work and collaboration.
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.
Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.
Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.
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.
Independently manages significant aspects of clinical trials and research projects.
Trains and provides guidance to less experienced staff, and oversees data management.
Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.
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.
Manage and track detailed milestones across all research projects, working with internal and external stakeholders to ensure success.
Assist with research administration including drafting service agreements, IRB submissions, and budget creation and tracking.
Support business development with due diligence of biobanks and creation of research protocols for new projects.
We are an innovative biomedical data company that helps healthcare institutions maximize the value of their biobanks through a secure, de-identified repository of clinical and molecular data. Founded in 2022 and backed by leading investors, we foster an inclusive, team-driven culture in a fast-paced startup environment.
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.
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.
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.
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.
Serve as primary point-of-contact and escalation point for clients, coordinating functional services and vendors to meet quality, scope, cost, and time objectives.
Manage study budget and financial health, ensuring projects remain within scope and identifying out-of-scope activities, while overseeing billing and forecasting.
Develop robust project plans with timelines and risk management, ensure quality management including eTMF inspection readiness, and lead internal and client meetings.
Precision for Medicine is a CRO that integrates clinical trial execution with scientific expertise and data sciences to accelerate life-changing therapies, focusing on Oncology and Rare Disease. It is a growing organization that values employee contributions and fosters a collaborative culture.
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.
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.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Lead and manage a team of Project Directors and Project Managers for global clinical trials.
Oversee project delivery, sponsor interactions, and profitability across clinical programs.
Ensure compliance with GCP/ICH and drive continuous improvement and KPIs.
Precision Medicine Group is a precision medicine company providing clinical research and development services. They emphasize quality, people, clients, and performance, with a collaborative team environment.
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.
Develop and maintain successful working relationships with study sites, serving as the primary point of contact for clinical trial operations.
Conduct monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements, preparing high-quality reports.
Collaborate with cross-functional teams including Clinical Project Managers, Data Management, and Regulatory Affairs to ensure end-to-end study execution.
CVRx pioneers unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. The company values commitments to others and fosters a culture of teamwork, collaboration, and positivity in a purpose-driven startup environment.
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.