Execute the clinical audit program, including scheduling, planning, reporting, and resolution of audits.
Ensure compliance with worldwide regulations, ICH-GCP, AbbVie policies, and sponsor requirements.
Provide advice and support on GCP and quality topics to business partners and support inspections.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. It is a large biopharmaceutical company committed to integrity, innovation, and community service.
Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
Maintain inspection readiness and support CRO oversight per ICH E6(R3).
Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.
Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.
Partner with Clinical Scientists and Clinician Services leaders to design and deliver study-specific training programs.
Develop calibration strategies, monitor clinician performance, and implement quality improvements.
Lead group training, coaching, and documentation while ensuring GCP and regulatory compliance.
Clario, part of Thermo Fisher Scientific, provides endpoint data solutions for clinical trials. Its global team has supported over 30,000 clinical trials and 70% of FDA drug approvals since 2015.
Lead and manage the assigned clinical operations team, setting and executing departmental strategy.
Oversee clinical trial agreements, budgets, and the timely execution of clinical research programs from conception through final study report.
Maintain oversight of study conduct at sites, ensure adherence to protocols and GCP, and serve as company representative at external meetings.
Iovance Biotherapeutics is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. As an end-to-end cell therapy company with fully owned, centralized U.S.-based manufacturing, it operates with a fast-paced, collaborative culture focused on bringing first-in-class treatments to cancer patients.
Manage all clinical operational aspects of global trials including start-up, conduct, and close-out.
Oversee CRO and site adherence to GCP and SOPs, proactively identifying and resolving study risks.
Lead study team meetings, build investigator relationships, and support protocol development.
Vera Therapeutics is a commercial-stage biotech focused on transforming autoimmune disease treatment, starting with the kidney. Founded in 2016 in Brisbane, CA, the company values empathy, ownership, clarity, and urgency in a collaborative, fast-paced team.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Support clinical development strategies and study execution across Phase 1-3 programs.
Oversee clinical safety and data review, partnering with CROs and internal teams to ensure quality.
Contribute to protocols, regulatory documents, and study reports for respiratory disease therapies.
Celea Therapeutics is a biopharmaceutical company dedicated to advancing transformative treatments for serious respiratory diseases, with its lead program in Phase 3 clinical development. As an early-stage, mission-driven team, Celea values accountability, transparency, collaboration, innovation, and passion.
Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
Oversee monitoring, compliance, and data analysis while mentoring junior staff.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.
Own the full post-sale journey for Kivo's customers, driving outcomes, retention, and expansion.
Lead end-to-end implementations of the Kivo platform, from solution design and configuration to validation and go-live support.
Serve as strategic partner and primary account point of contact, managing account health and partnering with Sales on expansion opportunities.
Kivo is a life-sciences SaaS platform specializing in quality management for pharmaceutical, biotech, and medtech organizations. It is a hyper-growth, fast-paced company focused on delivering customer success in regulated environments.
Lead analytical development and control strategy for sterile injectable/parenteral products from development through commercialization.
Define analytical CMC strategies and regulatory submissions, including NDA Module 3 content and specifications.
Oversee stability programs, method lifecycle management, and external CDMO and contract laboratory execution.
Kailera is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The company is an inclusive, team-oriented workplace with an entrepreneurial spirit focused on collaboration, integrity, and excellence.
Direct and manage a team of Project Directors and Project Managers in global project delivery.
Provide leadership and oversight for clinical programs and act as primary escalation point for sponsors.
Optimize profitability, manage resources, and ensure compliance with quality standards and regulations.
Precision Medicine Group provides clinical research and project management services for global clinical trials. The company promotes a culture centered on quality, people, clients, and performance.
Manage site and country level clinical trial operations, including vendor/CRO oversight and ensuring high-quality deliverables within timelines and budget.
Serve as the Clinical Operational Trial Lead with accountability for cross-functional delivery from protocol synopsis to Clinical Study Report and trial disclosure.
Ensure inspection readiness, data integrity, and compliance with SOPs, GCP/ICH guidelines, and FDA and state regulations.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and publicly traded on Nasdaq under DFTX, the company is relentlessly advancing a new generation of therapeutics with a mission-driven, collaborative culture.
Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.
Lead a centralized team of Data Coordinators to ensure accurate, timely, and complete clinical research data.
Manage workload, quality, and compliance for data activities across the Care Access site network.
Partner with clinical operations, sponsors, and CROs to resolve data issues and improve processes.
Care Access brings clinical research and health services directly to communities through hundreds of research locations and mobile clinics. They are dedicated to making health care more accessible and put people at the heart of medical progress.
Collaborate with project teams to support study startup and serve as primary point of contact for clinical sites.
Provide training on Beacon's devices and protocols, monitor progress, and maintain GCP/ICH compliance.
Address operational issues via Zendesk and Asana and deliver actionable site feedback for workflow improvements.
Beacon Biosignals is transforming precision medicine for the brain with at-home EEG and cardiopulmonary monitoring platforms for clinical development and diagnostics. They foster a remote-first culture with hubs in Boston, New York, and Paris, emphasizing curiosity, simplicity, and empathy.
Lead planning, execution, and oversight of clinical studies across Latin America.
Act as primary client contact and ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
Mentor CRAs and partners while shaping country-level recruitment and monitoring strategies.
Precision Medicine Group provides clinical development, regulatory, and commercial solutions for life sciences companies. It fosters a collaborative, high-integrity culture with opportunities for growth and leadership in a global remote environment.
Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.