Lead quality assurance activities, ensuring high standards are maintained across clinical projects.
Guide teams in compliance with industry regulations and best practices while fostering a culture of continuous improvement.
Mentor QA staff and drive the quality objectives within a dynamic and growing organization.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. The system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Ensure adherence to regulations and contractual obligations.
Develop and update compliance policies and SOPs.
Conduct internal compliance audits and report findings.
Equip is a virtual, evidence-based eating disorder treatment program. They aim to ensure that everyone with an eating disorder can access effective treatment, operating in all 50 states and partnered with most major health insurance plans. Since its founding in 2019, Equip has maintained a fully virtual environment.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Lead the planning, execution, and management of clinical trials.
Ensure compliance with FDA, ICH-GCP, and other regulatory standards.
Supervise and mentor Clinical Research Associates (CRAs) and study coordinators.
Jobgether leverages AI to match candidates with fitting roles, ensuring quick and fair application reviews. They connect top candidates directly with hiring companies, who then manage the final decision-making process.
Enhance healthcare quality by overseeing performance improvement initiatives.
Ensure compliance with regulations and support data analysis.
Monitor quality metrics and drive projects to improve healthcare outcomes.
Jobgether is a platform that connects job seekers with potential employers, using AI to match candidates with roles. They focus on ensuring applications are reviewed fairly and efficiently.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
Perform review of executed batch records and test data and perform product disposition
Lead and support quality audits of contract service providers
Jobgether is a company that connects job seekers with employers through an AI-powered matching process. They focus on ensuring applications are reviewed quickly and fairly, and they value talent development.
Lead the development and implementation of regulatory and quality assurance strategies.
Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
Act as an internal SME (Subject Matter Expert) on regulatory requirements.
Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Develop strategy and manage set up activities.
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Regularly monitor and conduct evaluations of interactions.
Provide in-the-moment coaching to Advocates to improve their performance.
Ivy Rehab provides world-class care in physical therapy, occupational therapy, speech therapy, and applied behavior analysis (ABA) services. Their culture promotes authenticity, inclusion, growth, community, and a passion for exceptional care for every patient.