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US Unlimited PTO

  • Directs the operational oversight and execution of clinical site start-up.
  • Manages CRO relationship and oversight to ensure appropriate scope of work.
  • Develops collaborative relationships with investigative sites.

GCP CRO SOPs Clinical Operations

20 jobs similar to Director, Clinical Site Operations

Jobs ranked by similarity.

US

  • Assist with daily site activities, acting as the primary point of contact for the site.
  • Assist with training and mentoring research staff, upholding professional development goals.
  • Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.

Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.

$100,000–$170,000/yr
US

  • Assist with the development of the protocol and informed consent form and/or program design.
  • Manage vendor budgets, payments, and timelines.
  • Effectively track and report on internal project metrics and study progress.

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. They are focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and operates a state-of-the art infectious disease research facility. They provide a comprehensive compensation and benefits package.

Europe

  • Monitor and own the progress of clinical studies at investigative sites.
  • Coordinate all necessary activities required to set up and monitor a study.
  • Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.

Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.

US

  • Oversight for traveling clinical staff supporting decentralized operations at events and sites.
  • Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
  • Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff).

Care Access aims to improve the future of health for everyone. With numerous research locations and clinicians globally, they deliver research and health services to communities facing barriers to care.

Europe

  • Oversees all aspects of study site management to ensure patient safety is protected and quality of data is generated.
  • Independently conducts all forms of site visits in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
  • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.

Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics solutions, and a real passion for complex disease states. They strive to ensure employees feel appreciated through a multitude of benefits and value their ideas and contributions.

  • 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 plc is a world-leading healthcare intelligence and clinical research organization. ICON fosters an inclusive environment driving innovation and excellence.

US

  • Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs.
  • Establish and lead the clinical operations strategy, setting departmental goals.
  • Promote strong cross‑functional collaboration with internal stakeholders.

McKesson delivers products to healthcare providers. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient, focused on creating an inclusive environment with strong values.

US

  • Directly manage a remote team of Care Partners, providing guidance and support.
  • Design and improve operational processes to ensure high clinical quality.
  • Monitor key performance indicators to measure success across different teams.

Medsien provides scalable remote care management for a quality patient experience. Hundreds of organizations trust Medsien's technology solutions to implement remote care management programs, personalize every interaction, and improve the lives of the people who need it most.

US

  • Develop and report key quality metrics across all clinical programs and trials.
  • Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
  • Drive inspection readiness at local and global levels.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.

Europe

  • Management and operational delivery of the clinical elements within a trial.
  • Successful execution of assigned trials and ensuring completion of trial deliverables.
  • Identify challenges to study timelines/deliverables and offer creative action plans.

Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.

US

  • Own end-to-end sales: prospect, qualify, run discovery, design solutions, negotiate, and close new business with pharma and biotech sponsors.
  • Develop and grow senior-level relationships across clinical operations, digital health, and patient recruitment teams, positioning ProofPilot as a long-term partner.
  • Sell ProofPilot’s core offerings as integrated solutions that drive measurable ROI.

ProofPilot provides a clinical experience platform. They are a fast-paced startup, and the culture promotes building and deepening strategic client relationships.

Europe

  • Manages central laboratory and specialty vendors across clinical trials.
  • Provides support for sample related matters to clinical study teams.
  • Assists with vendor selection and oversight.

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.

$99,400–$124,200/yr
US

  • Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
  • Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
  • Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.

Global

  • Performs on-site or remote monitoring visit activities.
  • Identifies investigators and verifies qualifications and resources.
  • Trains investigational site staff and supports regulatory submissions.

Ergomed is a rapidly expanding full-service mid-sized CRO specializing in Oncology and Rare Disease. The company has operations in Europe, North America, and Asia, fostering an international culture with employee well-being and career development opportunities.

US

  • Coordinate and assist with trial start-up activities.
  • Facilitate resolution of laboratory queries.
  • Track and report on study progress.

Freenome is dedicated to changing the landscape of cancer through early detection. They value diversity and do not discriminate based on various statuses protected by law.

$65,588–$118,093/yr
US

  • Responsible for leading and managing early and late phase imaging projects.
  • Manage the study to contract specifications and timelines.
  • Prepare project plans and manage various study projects in varied phases of study lifecycle.

Perceptive's mission is to shape the future of clinical research. Our global team delivers unmatched scientific and technological expertise, global operational experience, and end-to-end solutions to help the global research community realize tomorrow’s new therapies.

$74,000–$83,000/yr
US

  • Provide day-to-day operational and administrative support to preclinical scientists.
  • Partner with Procurement, Legal, and Finance to support vendor onboarding.
  • Assist with budget tracking and spend visibility for preclinical and toxicology activities.

Amylyx is focused on treating diseases with high unmet needs. They are a clinical-stage company with an experienced team ready to take action.

US

  • Provide operational support for the Field Medical team.
  • Manage and optimize medical systems—including Veeva, data repositories, and reporting tools.
  • Develop, implement, and maintain SOPs and operational processes.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.

  • Own and manage ongoing relationships with oncology practice partners, ensuring clear, consistent communication between key stakeholders on both teams
  • Monitor and report on partnership performance metrics, providing actionable insights to partner practices and internal leadership
  • Continuously evaluate and optimize workflows to improve efficiency, performance outcomes, and overall partner experience, including adapting to new software releases or operational updates

Protocol Behavioral Health provides cancer-specific behavioral health treatment to patients by partnering with oncology clinics and cancer centers. The team consists of top tier executives and operators who have depth in experience across behavioral health, healthcare services and oncology payer relationships.

US

  • Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program.
  • Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and clinical trials.
  • Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.