- IQVIA (Durham, NC)
- **Overview:** **Plan and conduct independent clinical ( GCP ) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and ... technical, or related area, of which 3 years in Quality + Assurance Audits. GCP experience. Equivalent...training and experience. + Experienced in the conduct of clinical trial Investigator site audits. + Experience in the… more
- Mayo Clinic (Rochester, MN)
- …and provides the resources you need to succeed. **Responsibilities** **We are seeking a Senior Software Engineer focused on GCP Stack data pipelines and data ... expectations. You will be a member of a highly skilled team with deep GCP experience in Big Query, Dataflow, Data Fusion, Data Stream and other cloud technologies… more
- United Therapeutics (Silver Spring, MD)
- …+ 2+ years in a clinical process or operations role + Certified Quality Manager (CQM)-ASQ RQAP- GCP and/or ASQ-CQA + Experience providing support with trials ... role is responsible for the management and execution of clinical quality oversight activities in support of...biotech/pharmaceutical industry experience + 5+ years of experience within GCP Quality + GCP experience… more
- Walgreens (Deerfield, IL)
- …including disability/veterans". \#LI-TO1 **Job ID:** 1502790BR **Title:** Senior Site Quality & Training Manager, RWE Clinical Trials **Company Indicator:** ... **Job Description:** **Job Summary:** The Senior Site Quality and Training Manager...monitoring strategies to support a culture of excellence in clinical research. **Job Responsibilities:** + Oversee site quality… more
- HCA Healthcare (Brentwood, TN)
- …enables these solutions through requirements analysis, configuration, and deployments. The Senior Product Analyst will support quality compliance throughout each ... diversity and inclusion thrive? Submit your application for our Senior Product Analyst opening with HCA Healthcare today and...processes to maintain compliance with privacy practices (eg HIPAA), quality standards (eg GCP ), and regulations for… more
- University of Michigan (Ann Arbor, MI)
- Clinical Research Coord Senior Apply Now **Job Summary** The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) Clinical Coordinating ... opportunity/affirmative action employer. **Job Detail** **Job Opening ID** 256958 **Working Title** Clinical Research Coord Senior **Job Title** Clinical … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager, Clinical Supplies will manage the complete clinical ... clinical studies with regards to time, cost and quality standards. The incumbent is accountable for effectively managing...traceability. + Oversees CPOs to ensure compliance with GMP, GCP , applicable Clinical Trial Regulations and agreed… more
- e CancerCare (Fresno, CA)
- …Assures compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research. Responsibilities/Essential ... staff, subIs, and PIs complete and maintain appropriate certifications specific to clinical trial participation ( GCP , Conflict of Interest, FDA Focused, and… more
- IQVIA (Bismarck, ND)
- … trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices ( GCP ) and procedures set forth by IQVIA Biotech ... across programs such as SOPs, working practices, and related quality assurance forms. * Provide other project support to...annually * Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.… more
- University of Colorado (Aurora, CO)
- **Research Services Senior Principal Professional (Research Services Professional, Clinical Sciences) Open Rank** **Description** **University of Colorado ... Medical Campus** **Department: Emergency Medicine** **Job Title:** **Research Services Senior - Principal Professional (Research Services Professional, Clinical … more
- WuXi AppTec (Austin, TX)
- …be made and every disease can be treated." **Responsibilities** **Job Summary:** The Senior Clinical Research Associate is a critical position within the ... and is assigned as a study lead to manage clinical trial studies. The Senior CRA will...+ Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and… more
- University of Colorado (Aurora, CO)
- ** Clinical Science Professional (Open Rank: Entry- Senior )- Emergency Medicine** Clinical Science Professional (Open Rank: Entry- Senior )- Emergency ... Research Services Clinical Science Professional (Open Rank)** **Working Title: Clinical Science Professional (Open Rank: Entry- Senior )** **Position #795275 -… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The ** Senior Manager Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned ... large and/or complex clinical trials from study design, through execution, to study...study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior ...GCP guidelines as well as applicable SOPs regarding clinical safety + Performs clinical /medical data review,… more
- Astellas Pharma (Northbrook, IL)
- …the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice ( GCP ), and applicable regulations and guidelines from study ... work are encouraged to apply. **Purpose and Scope:** A Clinical Site Manager II (CSM II) serves as the...possible timeframe. + Ensure site compliance with study protocol, ICH- GCP , and local/country regulations. + Ensure ongoing adequacy of… more
- University of Colorado (Aurora, CO)
- ** Clinical Research Nurse ( Senior Principal Level)** **Description** **University of Colorado Anschutz Medical Campus** **Department: Emergency Medicine** **Job ... Title:** ** Clinical Research Nurse ( Senior - Principal Level)**...Advanced knowledge and understanding of federal regulations and Good Clinical Practice ( GCP ) + Ability to communicate… more
- University of Colorado (Aurora, CO)
- ** Clinical Research Coordinator (Entry Senior Level)** **Description** **University of Colorado Anschutz Medical Campus** **School of Medicine | Department of ... | Division of Addiction Science, Prevention and Treatment** **Working Title: Clinical Research Coordinator (Entry - Senior Level)** **Position: #00829020… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply ... strong relationships with BeiGene functional leadership (including but not limited to clinical Operation, Quality , Regulatory, CMC, and GRDS) to ensure alignment… more
- IQVIA (Durham, NC)
- …accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization (ICH) ... in applying, applicable clinical research regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization (ICH)… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Clinical Development - Neurology...group + Ensures clinical trials comply with clinical guidance, ICH, GCP , in agreement with ... clinical programs worldwide across all phases of clinical research. The Senior Director will oversee... results and provide a guidance to prepare high quality reports working with Medical Writing + Responsible for… more
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