- Aequor (Thousand Oaks, CA)
- Fully remote MCS Supply Chain Sr Associate Ideal candidate: Experience is document management. Very document orientation and detail oriented Description: Reports ... to ( Sr .) Mgr Clinical Supply Chain. Candidates will,...inspection readiness processes Experience with document management in eTMF ( Trial Master File) Good MS suite skills, with an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready...and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel:… more
- Beckman Coulter Diagnostics (Miami, FL)
- …lives with diagnostic tools that address the world's biggest health challenges. The Senior Clinical Research Associate for Beckman Coulter Diagnostics is ... in the life sciences or related field required with 5+ years of clinical trial experience in vitro diagnostics (IVD), medical device, or healthcare clinical … more
- Amgen (Washington, DC)
- …clinical trial experience OR + Bachelor's degree and 6 years of statistical clinical trial experience OR + Associate 's degree and 10 years of ... clinical trials safety assessment. As a Safety Statistician, Senior Manager, your key activities will include: + Represents...Qualifications:** + Doctorate degree and 2 years of statistical clinical trial experience + Master's degree and… more
- Actalent (New York, NY)
- Job Title: Senior Clinical Study Manager The Senior Clinical Study Manager is responsible for ensuring the successful execution and delivery of ... creation, and ensure compliance with quality measures and timelines. + Monitor clinical trial performance and quality metrics, escalating issues and proposing… more
- Lilly (Indianapolis, IN)
- …culture to ensure diverse voices/ideas are considered. + Serves as mentor for clinical development managers, clinical trial project managers and others ... clinical deliverables in support of submissions, inspections, and publications. The Clinical Development Program Lead reports to the Associate Vice President… more
- Texas A&M University System (College Station, TX)
- Job Title Clinical Trial Support - Contract Administrator Agency Texas A&M University Department Research Compliance & Biosafety Programs Proposed Minimum Salary ... assists with the development of outreach programs related to human subjects research. Clinical Trial Support Services- Drafts, reviews, and negotiates agreements… more
- University of Miami (Miami, FL)
- …institutional guidelines, tissue dissection, primary tissue culture. Assists in Phase I clinical trial related sample receipt, handling and documentation with ... SCCC has an exciting opportunity for a Full Time Sr . Research Associate 3 to work at...of our lab is to generate preclinical data for clinical translation. Relevant experience in immunology, cell biology, molecular… more
- Penn Medicine (Philadelphia, PA)
- …shape our future each day. Are you living your life's work? Job Title: Sr Administrative Services Associate Department: Physical Med Pier Location: Penn Medicine ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Penn Medicine (Philadelphia, PA)
- …our future each day. Are you living your life's work? Job Title: Sr Administrative Services Associate Department: Otorhinolaryngology Location: Hospital of the ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Associate / Senior Associate /Principal Associate - MQO Portfolio is to ... functional business areas, for example, medical writing, regulatory affairs, or clinical trial management. + Knowledge of quality systems + Ability to work… more
- Amgen (Washington, DC)
- …to inform and provide sound statistical guidance to areas and teams in clinical development, clinical trial biomarker (CTA) and companion diagnostics ... clinical development environment with the supervision of more senior staff. **Accountabilities** *Provide dedicated support for Exploratory Biostatistics *Execute… more
- Lilly (Indianapolis, IN)
- …semi-finished drug product batches for Indianapolis Parenteral products, including commercial and clinical trial materials to ensure high quality medicine (GMP ... Compliance) is released to market in a timely manner. + Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance. + Effectively review / approve GMP documents to ensure quality attributes are met (deviations, procedures,… more
- Bristol Myers Squibb (Madison, NJ)
- …Bachelors degree required + At least 5 years of relevant industry and clinical trial experience including specific experience with eCOA technologies and ... + Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and end to end eCOA operationalization in a… more
- IQVIA (Overland Park, KS)
- …Research Associate ! You'll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and ... phases as required. Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP/ICH and local… more
- Avania (OR)
- …for the key role of experienced Clinical Research Associate (CRA) or Senior Clinical Research Associate ( Sr CRA) As a CRA/ Sr CRA you will be ... for several studies running in parallel, in all associated clinical trial phases, from regulatory submissions to...3 + years of relevant work experience as a clinical research associate - CRA. + Attention… more
- WuXi AppTec (Austin, TX)
- …can 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 ...Education:** + Minimum of 4 years experience as a Clinical Research Associate in the pharmaceutical/biotech or… more
