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.
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.
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.
Primary DM contact for assigned clinical project(s) / program(s), ensuring that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost and success rate of bringing therapies to patients. They are expanding in Asia Pacific.
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.
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.
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, 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.
Lead and manage multi-level Clinical Specialists for clinical support and case coverage.
Develop and deliver clinical education to sales, clinical specialists, and OR staff.
Work cross-functionally with Quality, Regulatory, Marketing, and R&D to develop clinical education.
Calyxo, Inc. is a medical device company that addresses the profound need for improved kidney stone treatment. They are led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
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.
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.
Lead day-to-day data management activities for assigned clinical trials.
Oversee CRO and vendor data management deliverables to ensure timelines, quality, and compliance.
Ensure data integrity, consistency, and completeness through ongoing data review and cleaning.
Faeth Therapeutics is a clinical-stage oncology company advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program. They are a small, focused team where every person has direct impact and are united by a shared commitment to care deeply, create boldly, and never stop learning.
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.
Manage all aspects of Patient Support Center program operations and lead a team of Case Manager Supervisors.
Monitor team activity, Service Level Agreements (SLAs), and Key Performance Indicators (KPIs).
Serve as the subject matter expert (SME) for the Case Manager role and program needs with key stakeholders.
Novartis focuses on the needs of people and a community committed to meeting them through innovative science to improve lives. They foster a collaborative environment where individuals can learn and thrive together.
Lead a large clinical study or a series of related studies with minimum guidance.
Provide mentoring and training to lower-level Data Management staff assigned to your studies.
Develop or lead the development of the Data Management Plan for a clinical study.
Parexel provides Clinical and Consulting solutions to the world’s life sciences industry. They have a global breadth of clinical, regulatory and therapeutic expertise, and a proven track record spanning 40+ years.
We welcome professionals from a variety of backgrounds and experience levels within clinical research.
We look for those passionate about Clinical Operations, Site Enablement & Site Management, and Clinical Business Development Functions.
We also welcome professionals from Regulatory & Compliance, Feasibility & Patient Recruitment, and Patient Access & Healthcare Innovation.
Milestone One's mission is to bring clinical trials to a much broader range of sites and patients around the world. It is a fast-growing global startup operating in an international, multicultural environment that is always looking to connect with talented professionals who are excited to grow with us and contribute to its mission.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Hire, coach, develop and retain a high-performing team of primary care sales representatives utilizing available tools.
Deliver sales performance and relevant Brand Key Performance Indicators (KPIs) in order to meet or exceed district sales plan within expense budgets.
Oversee the daily in-field activity and day-to-day management of assigned team members to achieve results within specific district/geographical assignment.
Shionogi Inc. is a pharmaceutical company. They are committed to undertaking affirmative action; the company focuses on non-discriminatory employment practices.
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.