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.
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.
Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews.
Execute the yearly corporate audit plan, tracking audits and preparing detailed outcome reports for management.
Provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams.
Care Access is a clinical research company that brings world-class research and health services directly to communities. With hundreds of research locations and clinicians globally, they are dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Leads quality compliance, risk management, and vendor oversight programs to support late-stage development.
Manages inspection readiness, data integrity assessments, and regulatory authority interactions across GxP.
Provides senior-level quality judgment and drives risk-based decisions in a dynamic environment.
Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy and other cardiovascular diseases. It has a proven leadership team, strong financial foundation, and a high-value late-stage asset, offering an opportunity for mission-driven professionals.
Provide quality oversight and direction to vendors to ensure cGMP compliance for clinical manufacturing.
Lead clinical lot disposition, batch record review, and QP certification for global trials.
Oversee GMP quality systems including deviations, investigations, and audits at contract manufacturing partners.
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.
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 global pharmacovigilance audits, regulatory inspections, and readiness planning.
Oversee issue management, deviations, root-cause analysis, and CAPA activities.
Develop and manage the global pharmacovigilance training program and procedural documentation.
Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.
Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
Manages vendor selection, oversight, and study-related training, and proactively resolves issues.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.
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.
Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.
Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.
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.
Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, packaging, and labeling.
Lead resolution of deviations, OOS/OOT, change controls, CAPAs, and product quality complaints with risk-based decisions.
Represent Product Quality on CMC and external partner teams to support development, regulatory submissions, and commercialization.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company values trust, ownership, curiosity, and results, fostering a culture of diversity and inclusion with a small but dedicated team.
Lead end-to-end GCP auditing processes, including scheduling, conducting, reporting, and follow-up for sites, vendors, and internal processes globally
Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve compliance issues and represent GDQA on cross-functional teams
Develop risk-based audit strategies, mentor new staff, and support regulatory inspections with 6+ years of experience including 4+ years direct GCP auditing
Regeneron is a leading biotechnology company that invents life-changing medicines for people with serious diseases. Founded and led by physician-scientists for over 30 years, we have developed nine FDA-approved treatments and numerous candidates, fostering a culture of innovation recognized as a Great Place to Work.
Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
Manages external vendors, recruitment strategies, and cross-functional team coordination.
Maintains inspection readiness and contributes to risk management and process improvement.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.
Support GMP CMC operations including review of batch records, analytical data, and product release for clinical-use drug substances and products.
Manage quality oversight for GMP vendors, audits, and quality agreements, and act as a QA point of contact for internal and external partners.
Review and approve quality events such as OOS, deviations, CAPAs, and change controls to ensure regulatory compliance.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer, targeting the RAS/MAPK pathway. With a small, collaborative team and a casual, mission-driven culture, they are committed to erasing cancer.
Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements.
Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables.
Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.
Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.
Lead statistical activities for clinical trials, primarily in Oncology, and act as the lead statistician overseeing strategy and deliverables.
Author key documents including Statistical Analysis Plans (SAPs), Analysis Database Specifications, and statistical sections of clinical study reports.
Collaborate with cross-functional teams, communicate results to stakeholders, and ensure regulatory compliance with FDA, ICH, and GCP standards.
ClinChoice is a global full-service CRO specializing in clinical development for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience and 4,000+ professionals across 20+ countries, we foster a quality-driven, one-team culture with below-average turnover and a focus on continuous training.
Lead protocol development including study design and statistical analysis plans for clinical trials.
Provide statistical oversight, mentoring, and training to ensure high-quality project delivery.
Manage statistical activities across projects, ensuring accuracy and consistency with regulatory standards.
ClinChoice is a global full-service CRO specializing in clinical development for pharma, biotech, and medical device companies. With over 4,000 professionals across 20+ countries, they foster a quality-driven, one-team culture and emphasize diversity and low turnover.
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 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.