- Parexel (Honolulu, HI)
- …Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the ... audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures...in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential… more
- Parexel (Honolulu, HI)
- The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable… more
- Parexel (Honolulu, HI)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical ... and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for… more
- Parexel (Honolulu, HI)
- …Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your ... Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group...for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director. To excel in… more
- GRAIL (Honolulu, HI)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome ... + MS or PhD with 10+ years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or… more
- Parexel (Honolulu, HI)
- …Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for ... and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to… more
- Abbott (Honolulu, HI)
- …planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the US Abbott EP team, you will provide ... clinical and technical support in a hospital setting, utilizing...lab and/or operating room setting. + Acting as a clinical interface between the medical community and the business.… more
- Fujifilm (Honolulu, HI)
- **Position Overview** The Associate Clinical Specialist independently provides customer support of Fujifilm's ES equipment in the Endoscopy department and/or ... catalog for assigned customers. It serves as the primary clinical resource for the Company and its sales team...and prevent future handling damages. + Serve as a clinical liaison by developing and delivering comprehensive weekly and… more
- Sumitomo Pharma (Honolulu, HI)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate ** **Medical Director, Clinical Development - Oncology** . The ... director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key… more
- Medtronic (Honolulu, HI)
- …resume._ * High School Diploma or GED AND a minimum of 8 years of patient care/ clinical experience; or * Associate 's Degree AND a minimum of 6 years of patient ... A valid driver's license is essential for this role. At Medtronic, the Senior Clinical Specialist supports the Pelvic Health Therapy groups in the areas of surgical… more
- Queen's Health System (Honolulu, HI)
- …environmental conditions. IV. MINIMUM QUALIFICATIONS: A. EDUCATION/CERTIFICATION AND LICENSURE: * Associate 's degree; or two (2) years experience as a Registered ... Nurse, EMT, Paramedic, or certified instructor may be substituted for the educational requirement. * Current certification as a provider in Advance Cardiac Life Support (ACLS). * Current certification as an ACLS instructor B. EXPERIENCE: * Prior experience as… more
- CenterWell (Honolulu, HI)
- …part of our caring community and help us put health first** The Associate Director, Product Management Conceives of, develops, delivers, and manages products for ... customer use. The Associate Director, Product Management requires a solid understanding of...dynamic team of product management professionals dedicated to advancing clinical operations and technology solutions. Drive the strategic roadmap… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- **Job Summary** Under the direction of the Director/ Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the ... oversight and management of Otsuka clinical studies, including coordination with other relevant parties (eg,...communication of any variances in budget forecast to the Director/ Associate Director. * Establish communication flow with CRO and… more
- Sumitomo Pharma (Honolulu, HI)
- …Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable ... to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and ... responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a… more
- Sumitomo Pharma (Honolulu, HI)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part ... with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical … more
- Sumitomo Pharma (Honolulu, HI)
- …our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Associate Director, RBQM, provides study-level leadership for risk-based quality ... management across Phase 1-4 oncology clinical trials. Reporting to the Executive Director, Data Management, this role drives data-driven quality oversight, ensuring … more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical ... by Otsuka. This role is responsible to ensure that clinical and commercial products that may be classified as...quality standards. This role has global responsibility for directing clinical and commercial product quality to ensure global supply… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- **Job Summary** The Associate Director, Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at ... biologics-specific GMP requirements. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- The Associate Director, Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic area ... and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial). **Content Execution Direction** + Provide… more
