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.
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 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.
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.
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.
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 and manage a team of Project Directors and Project Managers for global clinical trials.
Oversee project delivery, sponsor interactions, and profitability across clinical programs.
Ensure compliance with GCP/ICH and drive continuous improvement and KPIs.
Precision Medicine Group is a precision medicine company providing clinical research and development services. They emphasize quality, people, clients, and performance, with a collaborative team environment.
Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.
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.
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.
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.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Provide comprehensive project coordination and administrative support for clinical research studies.
Coordinate meetings, maintain project documentation, and monitor tracking systems.
Support compliance with internal processes and assist with study startup, maintenance, and closeout activities.
The company is a clinical research organization that supports the development of life-changing therapies through innovative programs. It operates with global teams and fosters a collaborative, inclusive work environment committed to teamwork, integrity, trust, and respect.
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.
Coordinate participant recruitment start-up activities for assigned clinical trials, managing timelines and cross-functional communication.
Manage sponsor-funded recruitment budgets, including tracking, forecasting, and reporting to leadership.
Oversee external vendors and ensure participant-facing materials meet regulatory and sponsor requirements.
Our partner is a clinical research organization managing participant recruitment for clinical trials. This is a remote opportunity within a growing multi-site network that values cross-functional collaboration.
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 operational leadership and oversight of clinical data management activities across studies, ensuring high-quality, inspection-ready data.
Manage end-to-end data management from study start-up through database lock, with oversight of CROs, vendors, and internal stakeholders.
Drive data quality, compliance, and continuous improvement, serving as primary Data Management representative on cross-functional teams.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric disorders. It is headquartered in New York and publicly traded on Nasdaq under the symbol DFTX.
Provide high-level logistical support for clinical study operations, including study start-up, site management, and monitoring.
Develop and manage study-related documents such as protocols, informed consent forms, and monitoring plans.
Oversee clinical trial supplies, vendor management, and ensure compliance with regulatory requirements.
Natera is a global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health. Our team consists of highly dedicated professionals from world-class institutions who care deeply for our work and each other, working hard and growing quickly.