- Edwards Lifesciences (Denver, CO)
- …the Manager of Clinical Project Management** , you will manage clinical trials activities and ensure all applicable regulatory requirements are met. This ... role requires the ability to synthesize large sets of clinical trial data to support innovative operational...trial startup and early-phase execution for domestic US trials + Experience with RAVE databases (eg report/listing generation,… more
- Bausch + Lomb (Denver, CO)
- …**Key Activities:** + Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical ... form (ICF) development, site selection and communication with senior clinical trial sites regarding all logistics including...+ Provides clinical oversight and management for clinical trials to facilitate compliance with FDA… more
- Medtronic (Denver, CO)
- …Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial . + Leadership skills include strong communication, sense of ... This is a Research Specialist role reporting to the Clinical Lab Manager . The Clinical ...procedures and regulatory requirements. + Experience in medical device clinical product trials and governing regulations. +… more
- Sumitomo Pharma (Denver, CO)
- …understanding of Clinical business processes, requirements and technology systems supporting Clinical Trials (eg EDC, CTMS, ETMF, Payments etc.) + 7+ years ... seeking a dynamic, highly motivated, and experienced individual for the position of ** Manager , Clinical Systems R&D IT Business Applications** who will serve as… more
- University of Colorado (Aurora, CO)
- ** Clinical Trial Management System (CTMS) Program...of the team with the Oncore trainers and CTMS Manager to assure that the UCD research community has ... tasks with potentially conflicting priorities + Able to synthesize complex clinical trial information in order to facilitate decision making + Familiarity with… more
- Deloitte (Denver, CO)
- …flow, data architecture, and data mapping + Experience with solutions for data-driven trials and clinical development insights (ie: site burden, patient burden, ... role ends on 11/30/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components...4+ years of experience with Life Sciences Pharmaceutical R&D clinical data lifecycle. Experience to include introducing new technologies… more
- University of Colorado (Aurora, CO)
- …report to the Research Services Program Director, with additional oversight from the Clinical Trials Manager .This description provides a general summary of ... guidelines** **Examples of Duties Performed** **Regulatory- 40%** + Submit clinical trial protocols with applicable essential documents...FDA regulations + Ability to work on audits of clinical trials + Experience with databases and… more
- Norstella (Denver, CO)
- …Citeline is one of the world's leading providers of data and intelligence on clinical trials , drug treatments, medical devices and what's new in the regulatory ... of Citeline's Patient Engagement and Recruitment solutions, including patient-facing websites and clinical trial recruitment platforms, with a focus on complex… more
- University of Colorado (Aurora, CO)
- …that the pharmacy worksheet accurately reflects pharmacy staff at each site. + Manage Clinical Trial Support Unit (CTSU) database and roster new staff and ... delinquent data (>90 day past due). + Submit monthly clinical trial pipeline reports for the project...the project management teams to monitor activity on new clinical trials . + Assist with collection of… more
- Parexel (Denver, CO)
- …Legal will be responsible for providing contract management to support clinical trials . **Key Accountabilities:** **Contract Negotiations and Reviews** + ... Review and negotiate Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Informed Consent Forms (ICFs), either directly or as… more
- Merck (Denver, CO)
- …sound processes, procedures, and strategies for ensuring data integrity in our clinical trials . **Primary Responsibilities:** + Leads their own specific tasks ... and subject matter experts + Support the project lead/project manager for activities, which may include (but are not... Clinical Documentation, Clinical Quality Management, Clinical Systems Implementation, Clinical Trials ,… more
- Parexel (Denver, CO)
- …key personnel to implement and operationalize Precision Medicine goals within client clinical trials . Manages central laboratory and specialty vendors on low ... to moderately complex clinical trials . Performs other duties as necessary.... Performs other duties as necessary to ensure optimal clinical trial execution. **Key Accountabilities** **:** **Study… more
- University of Colorado (Aurora, CO)
- …than 50 research staff across 11 teams and programs. Research domains span clinical trials , pragmatic research, health services research, basic animal research, ... **Research Operations Manager ** **Description** **University of Colorado Anschutz Medical Campus**...degree from an accredited institution + Five (5) years clinical research or related experience that includes: + Three… more
- Otsuka America Pharmaceutical Inc. (Denver, CO)
- …adheres to the approved core scientific narrative and lexicon, accurately reflects clinical trial data, and maintains consistency across global materials + ... The Manager , Medical Core Content is a team-level operational...and production of scientific assets, ensuring they accurately reflect clinical data, adhere to the core scientific narrative, and… more
- Parexel (Denver, CO)
- …studies, as applicable and/or appropriate for the MD + Providing risk assessment of clinical trials for local sponsorship as needed with the support of the ... and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction...*Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical… more
- University of Colorado (Aurora, CO)
- …foundations, and industry. These studies include: basic research, translational and clinical trials ; multi-center and investigator-initiated trials ; and ... and service responsibilities. The overall determination of research and clinical activities (Movement Disorders & Functional Neurologic Disorders) and allocation… more
- Otsuka America Pharmaceutical Inc. (Denver, CO)
- The Manager , Evidence Generation, IME & Sponsorship Payments is responsible for supporting the strategic planning, execution, and operational oversight of evidence ... (eg, observational studies, registries, and investigator-initiated studies (IISs) /investigator-initiated trials (IITs)) + Manage study documentation, contracts, and vendor… more
- Sumitomo Pharma (Denver, CO)
- …+ Collaborate with Clinical Development to interpret safety data from ongoing clinical trials . + Serve as a subject matter expert in Pharmacovigilance, ... across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and… more
- Bayer (Denver, CO)
- …research (IIR) and research site identification; + Responsible for supporting clinical trial team and engaging with appropriate stakeholders for ... Bayer sponsored clinical trials . Support with data collection, feasibility...skills; + Excellent interpersonal skills; + Demonstrates understanding of clinical trial design; + Ability to critically… more
- University of Colorado (Aurora, CO)
- …track all clinical research revenue and ensures a 100% collection of all clinical trials and generates processes and systems to identify if/when clinical ... process and assists with preparing financial reports. + Promptly notify Grants Manager of contractual issues and potential problems; propose viable solutions. +… more