Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies.
Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies.
Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.
Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for cancer and autoimmune diseases. They have a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, and are advancing its mission to deliver new standards of care for patients.
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.
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.
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.
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.
Provide strategic leadership for biometrics across all clinical development programs.
Define and implement an integrated biometrics strategy supporting clinical trial design and data quality.
Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team and a strong financial foundation, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Lead end-to-end Clinical Data Management activities for assigned clinical studies.
Ensure clinical data are accurate, complete, consistent, and inspection-ready.
Drive proactive risk identification, issue escalation, and resolution across study teams and vendors.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease, guided by core values and focused on innovation.
Translate program strategy into integrated timelines, milestones, and deliverables.
Manage one or more highly complex R&D programs and/or high-profile partnerships.
Lead cross-functional program management activities supporting autoimmune clinical development programs.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. We are committed to transforming the future of treatment for autoimmune disease.
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.
Serve as the primary operational lead for assigned studies.
Partner with sponsors and CROs as a key point of contact.
Proactively identify operational risks, including enrollment challenges and protocol-related issues.
M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations. With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US.
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.
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.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools.
Manages distribution, collection and tracking of regulatory documentation.
Penumbra, Inc. is a global healthcare company focused on innovative therapies. They design, develop, manufacture, and markets novel products and has a broad portfolio that addresses challenging medical conditions.
Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities.
Support Clinical Trial Managers in overseeing CRO deliverables, timelines, issue escalation, and overall study operational performance.
Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, they've built a global team of over 100 employees headquartered in Boston, with a focus on advancing their lead asset. We encourage people from all backgrounds to apply and cultivate a culture where all voices are included.
Serve as the primary operational liaison to NMDP and other registry partners across clinical and commercial programs.
Design, implement, and continuously improve scalable donor cell acquisition processes supporting the commercial launch of Orca-T and Orca Bio's clinical programs, incorporating transplant center feedback and industry best practices.
Assess capacity constraints in apheresis and patient operations infrastructure across the transplant center and registry network and proactively engage partners on solutions.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Own a portfolio of jurisdictions and act as the operational lead for everything regulatory that happens in those geos.
Partner closely with engineering and product to drive requirements development and shape how registration and compliance products are customized per market.
Translate policy and legal direction into operational playbooks and translate field signal back into product priorities.
Breezy is a global, two-sided marketplace company.
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.