- Repligen (Waltham, MA)
- …Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager , SOX & ITGC Compliance to lead the design, implementation, and ongoing ... across ITGC and SOX processes.Utilize data analytics to enhance testing quality , reduce risk, and improve audit coverage.Stay current on regulatory requirements… more
- Genmab (NJ)
- …(SDTM) standards that support the scientific need of a study/program while ensuring quality , consistency and compliance to CDISC standards and other industry ... fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and integrity of Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP . The SDL is accountable ... issues with CRO/ vendors/ site/ country performance including serious quality incidents and serious breaches of GCP ....performance and management of 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and… more
- Formation Bio (New York, NY)
- …clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving ... forecasts, and resource allocation. Ensure all clinical trials comply with ICH- GCP , FDA regulations, and other applicable regulatory standards. Champion proactive… more
- Unknown (Boston, MA)
- …the organization's compliance with the highest standards, including GMP, GLP, GCP , GPV, and CSV. This role involves the oversight of GXP, data integrity, ... various entities, and the maintenance of efficient systems and processes to ensure compliance with regulatory requirements. The VP of Quality Assurance will also… more
- Unknown (San Francisco, CA)
- …bioanalytical assay platforms. The ideal candidate will have a strong background in GCP , GLP, and GCLP compliance , and experience in supporting biomarker ... clinical biomarkers, clinical operations, biometrics, clinical pharmacology, regulatory, and quality teams. The successful candidate will be expected to bring… more
- Huntington National Bank (Chicago, IL)
- Description Role Overview / Summary + The Sr Engineering Manager will serve as the opinion leader and accountable owner for the strategic Enterprise Query Hub (EQH) ... platform on Google Cloud Platform ( GCP ). EQH is the operational data store that consolidates...plans, risks, and outcomes to business, technology partners, and risk/ compliance stakeholders. + Operational data store design: Own data… more
- Takeda Pharmaceuticals (Boston, MA)
- …Takeda Development Center Americas, Inc. is seeking a Clinical Program Quality Manager with the following duties: Support GCP compliance activities for ... teams and quality functions to identify and mitigate systemic GCP compliance issues across oncology programs; analyze and report compliance metrics… more
- Dignity Health (Phoenix, AZ)
- …regulations. * Support regulatory submissions and inspection readiness by ensuring privacy and quality compliance . * Establish and maintain robust quality ... the most promising first-in-class therapies for brain tumor patients. The Ivy Compliance Project Manager is responsible and accountable for supervising Ivy… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Sr. Manager , Clinical Quality serves as a key leader within the Medical Affairs organization, responsible for overseeing a team ... dedicated to ensuring regulatory compliance , Good Clinical Practice ( GCP ), subject safety,...**maker of possible** with us. **Job Summary:** The Sr. Manager , Clinical Quality serves as a key… more
- HCA Healthcare (Nashville, TN)
- **Description** **Introduction** Do you have the career opportunities as a Manager , Data Quality you want with your current employer? We have an exciting ... expertise! **Job Summary and Qualifications** Job Summary The Data Quality (DQ) Manager within the Data Office,...Quality , RDM, and governance on Google's Cloud Platform ( GCP ). + Consult on deep dives into extremely complex… more
- Confluent (Washington, DC)
- …Role:** We are seeking a highly experienced and technically proficient **Staff Risk & Compliance Program Manager (Insider Threat)** to join our Trust & Security ... time, within budget, and to a high standard of quality . **Engineering Partnership:** Act as the primary liaison between...alert on anomalous or high-risk user behavior. **Policy and Compliance :** Partner with Legal and HR to ensure all… more
- ThermoFisher Scientific (Morrisville, NC)
- …Overview** Lead internal audits at Thermo Fisher Scientific as an Audit Manager . Ensure compliance with global regulations. **Key Responsibilities** Internal ... centered on risk management for GxP domains (GMP, GLP, GCP , GDP, etc.) that aligns with corporate quality...+ Periodically adjust the plan based on emerging risks, compliance history, regulatory updates, and business priorities. + Conduct… more
- Abbott (Plymouth, MN)
- …people to restore their health and get on with their lives. As the Senior Manager Quality Engineering, you'll provide leadership and guidance for the quality ... objectives, mission and vision and FDA/ISO regulations; assures the overall quality of products meet internal and external customer requirements. **What** **You'll**… more
- ARTIDIS (Houston, TX)
- …visits (site initiation and training, monitoring, and close-out) following national regulations, GCP , and quality standard operating procedures as set out in ... designed and supervised directly by ARTIDIS. The Clinical Study Manager is an integral part of the Clinical Operations...he/she is responsible that the study conduct is in compliance with the approved study protocol and Good Clinical… more
- Mount Sinai Health System (New York, NY)
- …resources and allocate tasks to ensure timelines and objectives are met. **Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere to Good ... **Job Description** The **Project Manager II** will oversee the entire portfolio of...Develop and implement best practices to enhance efficiency, data quality , and compliance . + Monitor industry trends… more
- ThermoFisher Scientific (Greenville, NC)
- …with the Project Manager to ensure the necessary training, tracking and quality systems are in place for the clinical management team and be primarily ... of allocated studies, of moderate to high complexity, in compliance with ICH GCP . In accordance to...coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance … more
- Astellas Pharma (Dallas, TX)
- …and activate the site in the shortest possible timeframe. + Ensure site compliance with study protocol, ICH- GCP , and local/country regulations. + Ensure ongoing ... **Clinical Site Manager - TX** Do you want to be...assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating… more
- Capital One (New York, NY)
- Manager , Network Security, Tech & Data Risk Management _Capital One is one of the fastest growing organizations in the world today, powered by our passion for our ... innovation through technology, we equally prioritize cybersecurity, reliability, software quality , and data management._ _Technology & Data Risk Management (TDRM)… more
- J&J Family of Companies (Irvine, CA)
- …ensuring the successful performance and delivery of project deliverables, on time with high quality . The Clinical Research Manager with be a part of the Clinical ... Job Description Johnson & Johnson MedTech, Electrophysiology, is recruiting a **Clinical Research** ** Manager .** This role is based in Irvine, CA on a hybrid work… more
