Lead clinical trial strategies and evidence-generation initiatives for diagnostic product development and regulatory submissions.
Serve as a scientific expert guiding study design, interpreting clinical data, and collaborating with stakeholders.
Ensure successful clinical programs across US and EU markets, ensuring scientific rigor and regulatory alignment.
The company develops innovative diagnostic solutions. They foster a collaborative environment emphasizing scientific excellence, continuous learning, and impactful solutions.
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.
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.
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.
Serve as the site manager, ensuring data entry and query resolution, and maintain high-quality data and audit readiness at clinical sites.
Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.
Manage device accountability, inventory, distribution, and regulatory documentation to ensure compliance and audit readiness.
Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products for challenging medical conditions. The company sells its products to hospitals and healthcare providers worldwide through direct sales and distributors.
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 the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.
Lead design and execution of clinical trials for novel antibody-based therapies in rheumatology and I&I diseases.
Collaborate cross-functionally with clinical operations, regulatory, translational science to ensure robust study designs and data quality.
Interpret clinical data and present findings internally and externally, supporting regulatory submissions and scientific publications.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation therapies for immunology diseases. As a small, young company, it fosters a fast-paced, collaborative culture focused on advancing meaningful medicines for patients.
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.
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.
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.
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.
Conduct risk-based quality control assessments and on-site visits to ensure investigational sites adhere to study protocols, GCP, and company procedures.
Develop and maintain study-specific QC plans, tools, and reports, and drive trend analysis and issue resolution with clinical operations teams.
Support inspection readiness and contribute to training and process improvements based on QC findings and regulatory insights.
Zai Lab is a commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and worldwide. Founded in 2014, the company has a global team of about 2,000 employees, with a strong commitment to gender diversity and a culture that promotes women in biotech.
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.
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 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.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.
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.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Lead clinical strategy in Diagnostic Imaging, collaborating with cross-functional teams to design and evolve care management offerings.
Provide subject matter expertise in client-facing discussions and support growth efforts through travel and partnership cultivation.
Monitor program performance and drive continuous improvement, ensuring value for health plans, systems, and ACOs.
Cohere Health uses clinical intelligence and AI to streamline healthcare decisions for payers and providers, improving collaboration and reducing administrative burden. Backed by leading investors, the company has been named to the Inc. 5000 list and ranks as a Top 5 LinkedIn Startup for 2023 & 2024, with a supportive, growth-oriented culture.