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  • Lead execution of RBQM strategy across complex clinical trials, including risk assessments and monitoring plans.
  • Partner with cross-functional teams and CROs to identify, track, and mitigate risks proactively.
  • Ensure compliance with global regulations, drive process improvements, and report KRIs to leadership.

Clinical Operations Risk Management ICH-GCP Regulatory Compliance

16 jobs similar to Sr. Clinical Risk Manager

Jobs ranked by similarity.

US

  • Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
  • Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
  • Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.

Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.

Europe

  • Manage and oversee all clinical aspects of trials across multiple countries, ensuring timeline adherence, quality, and scope.
  • Lead CRAs and collaborate with cross-functional teams to achieve high client satisfaction and smooth trial operations.
  • Identify risks, develop creative action plans, and maintain focus on study priorities through effective communication.

Precision for Medicine is a precision medicine CRO that combines novel trial designs, advanced biomarker analytics, and deep oncology expertise to accelerate drug development. The company fosters a dynamic, high-energy culture and values dedicated professionals who thrive in challenging environments.

US

  • Manage all aspects of clinical trials from start-up through close-out, ensuring timelines, costs, and quality metrics are met.
  • Oversee vendor/CRO selection and management, study contracting, budgeting, and forecasting.
  • Lead study-related activities including protocol preparation, investigator selection, and training, and collaborate with cross-functional teams.

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.

US

  • Accountable for leading assigned clinical research activities and partnering with stakeholders on study design.
  • Conducts on-site and remote site visits, including qualification, initiation, monitoring, and close-out.
  • Tracks study progress, manages budgets, and mentors junior clinical study managers.

Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. With over 25 years of experience, the company fosters an inclusive and diverse team culture where employees are empowered to do their best work.

US

  • 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.

US

  • 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.

Global

  • Manage a team of 15-17 Study Management Associates (SMAs) to deliver best-in-class study execution.
  • Drive performance management, mentoring, and professional development for direct reports.
  • Support resource management, adherence to regulations, and continuous process improvements.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates across several therapeutic areas including immunology, oncology, and neuroscience, with a significant global presence and a culture focused on innovation and impact.

US

  • Develop and evolve a clinical governance framework adaptable across markets, including policies, standards, and oversight structures.
  • Design quality monitoring programs and track key clinical quality metrics to ensure consistent, safe telehealth services.
  • Partner with regional teams on regulatory compliance, risk mitigation, and continuous improvement initiatives.

HeliosX is a healthcare platform that makes healthcare faster and more accessible, operating proprietary brands like MedExpress and Dermatica with vertical integration. With over 1.7 million patients treated in 2025 and £781m in revenue, we are a fast-growing, profitable company with a culture of discipline and clinical excellence.

$80,000–$120,000/yr
US Unlimited PTO

  • 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.

Canada

  • Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
  • Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
  • Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.

Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.

US Eastern Time Zone US Central Time Zone Unlimited PTO

  • Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
  • Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
  • Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.

CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.

Latin America

  • Oversee Trial Master File (TMF) activities including document review, quality checks, and study-level engagement to ensure regulatory compliance.
  • Manage a team of Documents Specialists, Quality Review Specialists, and TMF Leads, providing training, performance management, and support.
  • Collaborate with leadership to drive process improvements and ensure efficient records management across clinical programs.

Precision Medicine Group is a contract research organization providing clinical research services. The company is expanding across Latin America and fosters a collaborative, quality-focused culture.

US

  • 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.

Canada

  • Lead the enterprise risk management function to identify, assess, and mitigate risks across the organization.
  • Develop and implement risk management strategies and frameworks that align with business objectives.
  • Collaborate with cross-functional teams to ensure risk considerations are integrated into decision-making processes.

Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without hidden fees or compounding interest. It is a remote-first company with a core value of people come first, offering competitive benefits.

  • Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
  • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
  • Collaborating with investigators and site staff to facilitate smooth study conduct.

ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.

Brazil

  • Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
  • Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
  • Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.

Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.