Develop and execute QC strategy to support clinical product testing and commercial launch.
Lead and provide oversight of analytical method validation and lifecycle management.
Lead complex investigations and champion data integrity principles.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka is building its core team and is looking for top talent who are passionate about making a difference.
Develop, mentor, manage and coach SSU personnel to ensure quality standards.
Ensure SSU personnel work to the highest quality standards and maintain compliance.
Participate in the interview process for new SSU personnel by conducting CV review.
Precision for Medicine is a Clinical Research Organization with an integrated offering enabling the science of precision medicine. They combine clinical trial designs, operational and medical experts, biomarker and data analytics solutions, with a passion for rare diseases and oncology.
Partner with Clinical Operations leadership to support clinical trial execution.
Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites.
Provide guidance and oversight to CRAs, including trip report review and training support.
Immatics is dedicated to making a significant difference in the lives of cancer patients. They are a global frontrunner in precision targeting of PRAME, found in over 50 cancers, with cutting-edge science and a strong clinical pipeline.
Management and oversight of a quality team conducting quality assurance activities.
Responsible for the successful execution of the Quality Improvement Program in accordance with CMS requirements.
Plans, organizes, and directs activities of Clinical Quality, including planning, training, and staff development.
HealthEdge is committed to workforce diversity and actively encourages all qualified persons to seek employment. They provide effective and efficient solutions to complex business problems.
Leads a team of clinicians and serves as a senior clinical owner for care delivery workflows.
Provides clinical support for program development and customer-facing clinical work.
Partners closely with Operations, Product, Member Success, Clinical Outcomes, Legal, Commercial, Customer Success, Solutions Consulting, and Marketing.
Carrot is a global, comprehensive fertility and family care platform, supporting members and their families through many of life's most memorable moments. Its award-winning products serve all populations, from preconception care through pregnancy, IVF, male factor infertility, adoption, gestational carrier care, and menopause.
Set up, maintain, reconcile, and archive electronic and paper Trial Master Files
Track study status, enrollment, regulatory documentation, laboratory samples, and site start-up status for assigned clinical projects
Actively order and maintain ancillary clinical study supplies required for the conduct of clinical studies
Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Develop a deep understanding of customer workflows.
Champion Qualio's agentic compliance solutions.
Become an in-house expert on Qualio's product.
Qualio is an agentic quality and compliance management platform that helps regulated organizations get products to market faster with reduced risk. The Qualio team is an all-remote, globally distributed workforce with teammates in over ten countries.
Own clinical quality strategy for a rapidly scaling network spanning 20+ states, 400+ clinicians, and multiple care models.
Build clinical compliance policy infrastructure that anticipates growth rather than reacts to it.
Lead and develop a team that grows with the organization.
Cartwheel builds a new kind of mental health program for kids that puts schools at the center, supporting school staff. They are an early-stage company backed by top investors and looking for mission-driven teammates.
Lead Headway's clinical quality strategy, developing protocols and processes that uphold safety, efficiency, and effectiveness standards for the practice.
Build and scale our Professional Practice Evaluation programs, directly improving clinical outcomes across our provider network of NPs and MDs/DOs.
Conduct routine chart reviews and monitoring, providing feedback to clinicians and creating remediation plans for documentation concerns
Headway is building a new mental healthcare system everyone can access by solving the biggest barrier to care: insurance. They are a Series D company with $325M+ in funding, looking for exceptional people to help them achieve their mission.
Monitor the progress of clinical studies at investigative sites or remotely, ensuring trials are conducted per protocol, SOPs, and regulatory requirements.
Conduct monitoring visits, review source documentation, verify data, and ensure accurate reporting of adverse events and protocol deviations.
Develop trial materials, contribute to SOPs, and maintain high-quality monitoring documentation and reports in required timelines.
Orca Bio is a late-stage biotechnology company developing next-generation purified cell therapies to redefine the transplant process for blood cancer patients. The company fosters a fast-paced, collaborative, and entrepreneurial start-up culture with a passionate team driven by core values and a mission to improve patient lives.
Design and own the QA program, including frameworks for sampling and audit cadence.
Build structured feedback loops to identify systemic quality issues and remediation opportunities.
Translate QA signals into data-backed narratives to influence prioritization across teams.
Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest. Affirm is a remote-first company that offers competitive benefits and focuses on providing a simple and transparent pay structure.
Serve as primary project coordinator for Quality Risk Management processes and strategic continuous improvement initiatives.
Collaborate with cross-functional teams to ensure compliant execution of quality risk activities and analyze QMS trends for improvement opportunities.
Provide administrative support, assist in authoring SOPs, and function as a Super User for QRM technology as needed.
Vertex Pharmaceuticals is a biotechnology company focused on discovering, developing, and commercializing innovative medicines for serious diseases. It has a global workforce and a culture centered on scientific research and improving patient lives through therapeutic breakthroughs.
Plan, lead, and manage clinical trials, developing comprehensive project plans for timelines, budgets, and deliverables.
Ensure regulatory compliance by working with the Compliance Team and preparing for audits, adhering to GCP guidelines and company SOPs.
Serve as a primary communication point for sponsors and internal teams, providing regular updates and building client relationships for future business.
Paradigm Health is a company rebuilding the clinical research ecosystem by enabling equitable patient access to trials and enhancing trial efficiency. The team, backed by leading investors like ARCH Venture Partners, is multidisciplinary and committed to creating equitable access to clinical trials for any patient, anywhere.
Supports all phases of clinical development and execution.
Ensures high quality data by being the study protocol expert and key site resource for questions.
Maintains and tracks clinical study data and supports investigator qualification selection.
SI-BONE is a medical device company focused on minimally invasive sacropelvic solutions. They aim to help patients with sacroiliac pelvic conditions and have provided over 90,000 procedures to date using their iFuse Implant System.
Lead a hematology program, overseeing all operational activities and strategic planning.
Provide leadership over CROs and vendors, ensuring timelines, quality, and budget expectations are met.
Collaborate with internal functional leads to drive integrated study execution, providing strategic direction.
Caribou Biosciences is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases using CRISPR genome-editing technology. They have a CAR-T cell therapy platform and headquarters in Berkeley, California.
Author, review, and manage clinical, regulatory, technical, and medical documents including protocols, study reports, and regulatory submissions.
Ensure strategic alignment and consistency of scientific messaging across documents while maintaining compliance with global regulatory requirements.
Drive the end-to-end writing process, manage timelines, and lead cross-functional reviews to deliver high-quality, on-time deliverables.
Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, focusing on cardiovascular indications. The company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders, empowering talented individuals to make a real impact.
Manage and motivate a team of CRAs to achieve Precision for Medicine’s quality standards.
Support the career development of the organization’s Clinical Research Associate (CRA) workforce.
Strengthen the quality and productivity of operations within the group.
Precision for Medicine is a Clinical Research Organization with a uniquely integrated offering. They combine novel clinical trial designs, industry-leading operational and medical experts, and advanced biomarker and data analytics solutions.