Source Job

• 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 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.

• 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.

• 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.

• Manage day-to-day relationships with pharmaceutical customers, identify growth opportunities, and provide ongoing communications.
• Provide subject matter expertise related to past industry experience during projects as appropriate.
• Draft/update project deliverables and well-organized presentations to a high level of quality.

Archbow Consulting leverages industry expertise in a consultant capacity to support pharmaceutical and biotech companies. They are committed to hiring and developing exceptional talent and focused on developing inclusive teams that can bring the best solutions.

• Leads projects from conception through close-out, ensuring detailed planning and execution, risk management, communication and stakeholder management, scope and cost control.
• Creates and manages project timelines, budgets and revenue goals, forecasting, resource plans, while comparing to contracted project scope(s), fully exploring new ideas that optimise quality and efficiency.
• As the face of the company and key partner to clients and collaborators, effectively leads implementation of new and ongoing studies.

Precision for Medicine accelerates the development and adoption of novel therapeutics. They focus on assay development and clinical testing, biorepository/sample management and logistics, and kitting for client studies spanning the globe.

• 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.

• Drive implementation from end to end, both internally and externally with client teams
• Partner with health plan and risk bearing provider clients to successfully launch Cohere Health products within their organization
• Act as the key liaison between client implementation team and cross functional teams at Cohere to drive day to day implementation activities

Cohere Health's clinical intelligence platform delivers AI-powered solutions that streamline access to quality care by improving payer-provider collaboration, cost containment, and healthcare economics. The company works with over 660,000 providers and handles over 12 million prior authorization requests annually, and is backed by leading investors such as Deerfield Management. The Coherenauts who succeed here are empathetic teammates who are candid, kind, caring, and embody our core values and principles.

• Manages complex cross-functional design and development projects on a first in class wearable device.
• Works with cross-functional team to ensure timely and complete deliverable execution.
• Identifies, analyzes, and tracks project risks and issues and monitors progress to plan.

Cognito Therapeutics, Inc. translates scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. They are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world.

• 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.

• 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.

• Develop client-ready deliverables including protocols, statistical analysis plans, and technical reports.
• Manage the delivery of project components by collaborating with other staff members.
• Contribute to development of proposals and presentations under guidance of senior team members.

Precision Medicine Group is a portfolio organization that helps its clients with sophisticated evidence synthesis projects. The company has a start-up culture with vision in its field.

• Partner with Regulatory leads to manage regulatory filing subteams and subteam operations.
• Develop and maintain high level and detailed regulatory timelines that utilize project management software tools.
• Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays.

Ultragenyx is a biopharmaceutical company committed to addressing unmet medical needs in the field of rare diseases. With a focus on innovation and patient-centricity, they strive to develop life-changing treatments and improve the lives of patients and caregivers.

• 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.

• 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.

• Contribute to the design of early/late-stage protocols across multiple therapeutic areas.
• Develop and write statistical analysis plans, and perform statistical analyses for interim and final reports.
• Support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy.

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, they focus on quality, professional development, and a supportive culture.

• 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.

• Manage software implementation projects from kickoff to go-live, coordinating cross-functionally.
• Proactively identify project risks and propose alternative solutions to keep timelines on track
• Configure client applications using a no-code flow builder, conduct quality assurance testing.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, they surpassed $3B in revenue in their last fiscal year with extensive growth potential ahead. They are a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

• 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.

• 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.