- Bausch + Lomb (Helena, MT)
- …**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
- Sumitomo Pharma (Helena, MT)
- …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
- Norstella (Helena, MT)
- …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
- Merck (Helena, MT)
- …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 (Helena, MT)
- …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
- Parexel (Helena, MT)
- …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
- Otsuka America Pharmaceutical Inc. (Helena, MT)
- …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 (Helena, MT)
- …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
- Sumitomo Pharma (Helena, MT)
- …+ 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
- Otsuka America Pharmaceutical Inc. (Helena, MT)
- 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