Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program.
Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and clinical trials.
Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.
Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
ICON plc is a world-leading healthcare intelligence and clinical research organization. ICON fosters an inclusive environment driving innovation and excellence.
Accountable for the operational management and execution of global clinical trial programs (Phases I-III). Ensure adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. Partner with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications.
Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities.
Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs.
Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease.
Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.
Lead site monitoring activities, while also supporting a broad range of clinical responsibilities, including process development, in-house operations, and study oversight.
Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.
Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.
CoMind is developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring.
Assist with the development of the protocol and informed consent form and/or program design.
Manage vendor budgets, payments, and timelines.
Effectively track and report on internal project metrics and study progress.
Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. They are focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and operates a state-of-the art infectious disease research facility. They provide a comprehensive compensation and benefits package.
Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.
This position is posted by Jobgether on behalf of a partner company.
Document and communicate audit findings to management and recommend corrective actions to improve compliance. Provide staff education on privacy standards, compliance policies, and regulatory requirements. Review, investigate, and respond to facility inspections and/or deficiencies issued by regulatory agencies.
SimonMed Imaging is the fastest growing outpatient radiology practice in the Nation and is committed to excellence and improving patient care.
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.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.
Responsible for operating, supporting, and developing the ISO Practice with a high level of quality, productivity, and satisfaction for both clients and employees. Oversees the delivery of ISO certification services, ensures compliance with accreditation requirements. Leads the development of the audit team to drive efficiency, profitability, and growth within the practice.
Insight Assurance is a global audit firm on a mission to transform how organizations achieve cybersecurity and compliance.
Complete monthly utilization management and appeals performance and process audits.
Present audit results to leadership to address issues.
Assist management in identifying, evaluating, and mitigating risks.
Judi Health provides a comprehensive suite of solutions for employers and health plans. They offer full-service health benefit management solutions and consolidate all claim administration-related workflows in one scalable, secure platform.
Responsible for leading the strategic direction, management, and oversight of the organization’s regulatory compliance program.
Manage a team of compliance professionals, ensuring that the company operates in full adherence to applicable laws, regulations, and industry standards.
Drive the development and implementation of enterprise-wide compliance frameworks, oversee risk assessments, support regulatory interactions, and champion a culture of compliance across the organization.
Truelogic is a leading provider of nearshore staff augmentation services headquartered in New York. Their team of 600+ highly skilled tech professionals, based in Latin America, drives digital disruption by partnering with U.S. companies on their most impactful projects.
The Upstream Senior Clinical Program Manager will design and execute pre-market feasibility and pivotal clinical studies, ensuring regulatory compliance while supporting marketing claims. This role requires close collaboration with physician collaborators and internal stakeholders to collect, analyze, and interpret clinical data. The role offers remote flexibility, with occasional travel for on-site meetings and conferences.
This position is posted by Jobgether on behalf of a partner company.