Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
Support regulatory team in preparing documents for study submissions and participate in feasibility research.
PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Lead analytical strategies for commercial products, ensuring compliant and robust methods and specifications.
Manage method transfers, validations, and lifecycle activities while collaborating with CDMOs and cross-functional teams.
Contribute analytical expertise to regulatory submissions and support health authority inspections.
The company is a science-driven biopharmaceutical organization focused on developing and commercializing small-molecule drugs. They foster a collaborative culture with engaged colleagues and emphasize scientific excellence.
Lead research governance and compliance processes for biomedical research programs, ensuring ethical and regulatory adherence.
Design data governance frameworks for sharing sensitive human data, balancing access with responsible stewardship.
Collaborate with scientific communities and institutional partners to implement governance systems that protect participant rights and research integrity.
Sage Bionetworks architects a more open, equitable, and data-driven scientific ecosystem by democratizing information and breaking down disciplinary barriers to accelerate research. Founded in 2009, this high-agility nonprofit fosters a culture of curiosity, innovation, and diverse perspectives, operating at the intersection of science, technology, and ethical data sharing.
Lead pharmacovigilance strategy and operations across the portfolio, ensuring regulatory compliance and safety oversight.
Oversee outsourced PV vendors, build quality systems, and manage safety data exchange agreements.
Partner cross-functionally with Clinical Development, Regulatory, and Quality to advance pipeline from early to late-stage development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a lean organization with a build-oriented culture, advancing a pipeline from Phase 1 to Phase 3.
Lead and execute risk-based internal audits across pharmaceutical and medical device operations.
Serve as Lead Auditor for complex, multi-site audits, driving continuous improvement of the QMS.
Support inspection readiness and regulatory authority/notified body audits.
Agilent Technologies is a global leader in laboratory and clinical technologies, providing instruments, software, and consumables for life science research and diagnostics. With 18,000 employees, we foster an inclusive, dynamic culture built on trust and integrity.
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.
Lead client-facing safety projects and serve as the primary point of contact for pharmacovigilance services.
Manage project scope, timelines, and deliverables while coordinating activities across PV teams.
Provide pharmacovigilance expertise including ICSR processing, aggregate reporting, and quality review.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses a shortlisting process to ensure fair and objective application review, and the final hiring decisions are made by the partner company.
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.
Lead multi-state expansion and regulatory compliance for a health insurance carrier.
Own rate and form filings, licensing, and regulatory relations with state Departments of Insurance.
Build, implement, and maintain compliance policies, monitoring programs, and risk reporting.
Evry Health is a large group health insurance carrier focused on multi-state expansion and regulatory compliance. The company is a lean, fast-moving organization with a remote-first culture, seeking a foundational hire to build its compliance function.