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 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.
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.
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.
Lead and oversee global drug development programs, ensuring alignment with strategic objectives and key milestones.
Facilitate cross-functional collaboration by coordinating program meetings, tracking decisions, and managing risks.
Drive effective decision-making, support budget planning, and mentor stakeholders to enhance operational excellence.
Our partner is a biotechnology or pharmaceutical company advancing innovative therapies through the full drug development lifecycle. They foster a fast-paced, mission-driven environment with cross-functional global teams, focusing on oncology innovation and healthcare impact.
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.
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 and maintain integrated project plans, drive cross-functional execution, and facilitate team meetings to ensure accountability and progress.
Proactively identify and manage risks, develop mitigation strategies, and support governance readiness with decision-focused materials.
Partner with cross-functional teams to improve planning, execution, and operational processes in a lean, fast-paced environment.
Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-based treatments for psychiatric disorders. The company is publicly traded on Nasdaq and fosters a culture of scientific rigor and innovation.
Manage execution of study-level activities, including creating trial documents and overseeing vendor delivery and budgets.
Coordinate country and regional trial management, aligning feasibility strategies and mitigating local risks.
Support program-level compound training and mentor new team members in Trial Management.
Johnson & Johnson is a global healthcare innovator focused on preventing, treating, and curing complex diseases through Innovative Medicine and MedTech. With a large workforce, they emphasize an inclusive work environment guided by their Credo, respecting diversity and dignity.
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.
Lead enterprise-wide project management initiatives within a mission-driven digital health environment.
Oversee complex, cross-functional programs from concept through delivery, ensuring alignment with strategic goals.
Establish scalable project management frameworks and executive reporting to enable effective decision-making.
This partner company operates in the digital health space, focusing on enterprise-wide project management initiatives. It is a growing organization with a collaborative and inclusive culture centered on accountability, respect, and continuous improvement.
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.
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.
Manage clinical elements of trials including site selection, start-up, enrollment, monitoring, and close-out for studies across multiple countries.
Lead CRAs and ensure timeline adherence, quality delivery, and effective communication with cross-functional teams and sponsors.
Identify risks to project timelines, create action plans, and mentor team members while maintaining focus on study priorities.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, biomarker and data analytics, with a focus on rare diseases and oncology. The company is part of Precision Medicine Group, a growing organization dedicated to advancing oncology development and positively impacting patient health.
Provide operational leadership and oversight for assigned FSP projects, managing regional trials or supporting complex global trials.
Serve as the primary operational point of contact for clients, coordinating cross-functional activities and monitoring project risks, resource constraints, and quality trends.
Contribute to financial oversight, meeting facilitation, and team onboarding, training, and mentoring.
Precision Medicine Group is a clinical research organization (CRO) focused on supporting clients researching ground-breaking cancer therapies. The company fosters a supportive, collaborative environment that promotes work-life balance and team development.
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.
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.
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.
Manage clinical operations including study management, biospecimen acquisition, and regulatory compliance.
Lead and mentor a team of CRAs and clinical trial logistics personnel.
Develop and implement processes and tools for high-quality trial management.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to delivering better solutions and have an innovative culture focused on collaboration and cutting edge solutions.
Provide strategic leadership and functional representation for complex projects, ensuring effective coordination and execution of regulatory tasks.
Act as a franchise liaison between Ergomed Plc and clients, assisting in securing new business by participating in bid defenses and contributing to proposals and budgets.
Offer expert regulatory guidance, training, and mentoring to junior staff, while driving department initiatives and managing change implementation.
PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. With a presence across Europe, North America, South America, Asia, and Australia, the company fosters a culture built on kindness, flexibility, growth, and belonging.