Source Job

• Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
• Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
• Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.

Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.

• Oversee GCP quality systems and provide QA leadership for global clinical operations including decentralized trials.
• Lead investigations, CAPAs, risk assessments, and audits to ensure regulatory compliance.
• Review clinical documentation, support vendor qualification, and mentor QA staff.

WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trial services, home health, and market access solutions. With over 15 years of global experience across 150+ countries, the company fosters a collaborative and mission-driven culture.

• Provide strategic quality oversight for global clinical operations, including decentralized clinical trials and patient-focused healthcare services.
• Ensure compliance with global regulations, sponsor expectations, and established quality systems through risk management and continuous improvement.
• Lead investigations, audits, and CAPA activities to support safe, efficient, and reliable clinical trial delivery.

The partner company is a mission-driven organization focused on improving access to healthcare solutions. They foster a supportive, inclusive, and collaborative work environment with a remote-first culture.

• Oversee strategic and operational execution of clinical trials, leading cross-functional teams and managing vendor selection.
• Direct clinical trial budgets, risk mitigation, and provide technical input into key clinical documents.
• Mentor staff and foster strong team relationships in a dynamic organization.

Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. The company was launched based on assets licensed from Paragon Therapeutics and has a growing pipeline.

• Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
• Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
• Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.

Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.

• Lead the execution and continuous improvement of quality management systems to ensure compliance with FDA, ICH, GCP, and ISO 9001 standards.
• Manage electronic Quality Management System (eQMS) including document control, CAPA, risk management, and audit processes.
• Provide quality oversight for clinical trial activities and software development lifecycle, collaborating with cross-functional teams.

The partner company is a fast-growing healthcare and life sciences organization focused on improving clinical research. It values collaboration, curiosity, and continuous improvement, and supports teams through scalable systems and risk management.

• Plan and conduct GxP audits (internal, vendor, site) to ensure compliance with FDA regulations and GCP.
• Develop risk-based audit plans, communicate observations, and track corrective actions until closure.
• Escalate critical deficiencies to leadership and support inspection readiness through key staff interviews.

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. As a subsidiary of McKesson, we bring together more than 1,300 physicians and have contributed to pivotal research that led to the majority of new cancer therapies approved by the FDA in the past decade.

• Manage operational activities for all phases of clinical studies, from start-up to close-out.
• Provide sponsor oversight of CROs and vendors to ensure compliance and quality.
• Support data review, TMF maintenance, and cross-functional collaboration for trial success.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing off-the-shelf cell therapies for devastating diseases. The company fosters an open, collaborative culture where diverse perspectives are welcomed, with teams working from Berkeley or remotely.

• Oversee critical monitoring activities across clinical trials, ensuring compliance with protocols and regulations.
• Collaborate with investigators and site teams to maintain study integrity and operational excellence.
• Support Phase II and Phase III trials in challenging therapeutic areas to improve patient outcomes.

Jobgether uses artificial intelligence to match job seekers with opportunities through a fair and efficient process. As a growing platform, they emphasize collaboration, integrity, and patient impact in their culture.

• Lead and develop clinical operations teams, overseeing oncology trial execution from feasibility to closeout.
• Drive process improvements and operational excellence to enhance study delivery and site performance.
• Ensure compliance with regulations, manage budgets and resources, and foster stakeholder relationships.

The company is a global clinical development organization focused on advancing oncology therapies through clinical trials. It fosters a collaborative and inclusive work environment with opportunities for professional growth and continuous learning.

• Independently manage all operational aspects of Phase I clinical trials from startup through closeout, ensuring adherence to protocols and regulations.
• Oversee CROs and vendors to ensure alignment with study goals, budget, and timelines.
• Lead the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource.

Absci is a clinical-stage biotechnology company leveraging generative AI for drug discovery through its Integrated Drug Creation platform. The company has a global presence with offices in the US, Switzerland, and Serbia, and fosters a collaborative, innovative culture.

• Manage and oversee the GCP Quality Management System for global clinical operations, including decentralized trials.
• Lead quality investigations, CAPAs, and audits to ensure compliance with regulatory standards.
• Provide strategic quality advice and drive continuous improvement across the organization.

WEP Clinical partners with biopharmaceutical sponsors to bring treatments to patients through clinical trial delivery and home health services. With over 15 years of global experience, the company fosters a collaborative, innovative culture focused on improving patient outcomes.

• Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
• Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
• Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.

Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.

• Provide operational leadership and on-site support for multiple clinical research sites, ensuring study execution and performance.
• Ensure compliance with GCP, FDA regulations, ICH guidelines, and internal quality standards through audit readiness and CAPA management.
• Build trusted relationships with Principal Investigators, site staff, and sponsors to drive collaboration and operational excellence.

We are a leading community site network and home research visit solution provider with 20+ sites and over 2,000 research-experienced healthcare professionals across the U.S. We leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access and reduce study costs.

• Provide sponsor oversight of CMO QC labs and maintain control strategies for investigational cell therapy products.
• Manage validation of analytical methods and stability programs to support clinical trials.
• Investigate laboratory deviations and ensure risks are managed to resolution.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values of innovation and collaboration, they are a growing company committed to transforming treatment for autoimmune disease.

• Lead all clinical study operations, providing strategic planning and direction from inception through completion.
• Serve as the primary contact with sponsors and oversee study budgets, timelines, and vendor management.
• Mentor and motivate study team members while ensuring compliance with GCP, protocols, and regulatory requirements.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Our team of skilled professionals is committed to advancing clinical research with care, integrity, and excellence, fostering a collaborative and supportive culture.

• Lead quality assurance activities to support patient safety and pharmacovigilance compliance across global operations.
• Plan, conduct, and manage pharmacovigilance audits, CAPA programs, and regulatory inspection readiness activities.
• Collaborate with cross-functional teams including clinical development, regulatory affairs, and medical affairs to maintain robust quality systems.

This company is a science-driven healthcare organization focused on pharmacovigilance and patient safety. They operate in a collaborative, global environment committed to operational excellence and meaningful healthcare impact.

• Manage a team of 6-14 CRAs to ensure excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP.
• Provide training, support, and mentoring to CRAs, manage low or non-performance situations, and contribute to capacity planning.
• Collaborate with local stakeholders, including CRMs and PLMs, to ensure alignment across monitoring functions and resolve site or CRA operational issues.

We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare, supported by a large and diverse workforce.

• Lead and manage the Clinical Solution Analyst team, overseeing resourcing, performance, and career development.
• Act as a senior product subject matter expert, shaping solution design and providing delivery insights to inform the product roadmap.
• Partner with Sales to support feasibility assessments and with customers to ensure successful onboarding and delivery.

Evinova is a health-tech business focused on accelerating better health outcomes through digital transformation in the life sciences sector. The company fosters a collaborative, fast-paced culture with a shared purpose to transform health through data and digital innovation.

• Lead site activation strategies and oversee start-up activities across clinical studies.
• Manage critical path plans and mitigate risks to ensure timelines are met.
• Collaborate with cross-functional teams and clients to improve activation processes.

Our partner is a clinical research organization that supports the delivery of clinical trials. They are a global company with a collaborative culture focused on innovation and operational excellence.