- BeiGene (Emeryville, CA)
- …study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an...meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role… more
- Dana-Farber Cancer Institute (Methuen, MA)
- …documents as it pertains to participation in clinical trials across all studies open at the Regional Campus site(s). Ensures timely collection of protocol ... informed consent (minimal risk studies ), and register study participants to clinical trials. **This is...as it pertains to the Regional Campus studies . Maintain and organize study regulatory binders,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …these activities, and is accountable for the successful design and interpretation of clinical studies . Presents study conclusions to Management and determine ... **Synopsis / Protocol Development, Study Execution, & Study Interpretation** . Drives clinical science activities...recommendations received into the design of clinical studies / programs as appropriate; accountable to senior… more
- Takeda Pharmaceuticals (Boston, MA)
- …activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies . Serves as an advisor to the clinical scientists ... and empower you to shine? Join us as a Senior Medical Director, Oncology Clinical Science in...**Synopsis / Protocol Development, Study Execution, & Study Interpretation** + Drives all Clinical Science… more
- Astellas Pharma (Northbrook, IL)
- …with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall ... work are encouraged to apply. **Purpose and Scope:** A Clinical Site Manager III (CSM III) serves as the... Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager… more
- Abbott (Dallas, TX)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** The ** Senior Clinical Site Lead** for the **Dallas/Fort Worth, TX** region ... competent authority/ethics committee. Beyond developing and maintaining a productive clinical territory, the Senior Clinical ...+ Deepen area(s) of expertise and function as a regional clinical and technical resource. + Utilize… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Committees, Medical/Patient Societies). + Responsible for optimal planning and execution of clinical studies from FIM throughout pivotal, ensuring integration of ... and planning of Clinical Trial Report. Leads clinical interpretation of study results and ensures...the relevant disease area, project and budget management for studies , ability to communicate clearly. **Director, Clinical … more
- IQVIA (Durham, NC)
- Senior Clinical Leads are an integral...for clinical delivery of full service, large, multi- regional studies to meet contractual requirements and ... Study Leadership, you will work as the primary Clinical Lead to deliver large, global MASH trials. The Senior Clinical Lead is a member of the core… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …vaccine development plans, clinical study designs, statistical analysis plans, and clinical assays for vaccine clinical studies . + Serve as an ... a key member of the Vaccine Development team, the Senior Program Officer, Pandemic Product Development & Clinical...advisor on clinical vaccine study design; including the review of protocols, analysis plans,… more
- Integra LifeSciences (Irvine, CA)
- …forecasting, pricing strategies, literature/video/sales support materials, labeling revisions, clinical studies , manufacturing and customer service/operations ... the value of the product line + Demonstrates strong clinical aptitude and ability to discuss clinical ...strong clinical aptitude and ability to discuss clinical matters with customers + Builds and maintains active… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for clinical studies within the overall global clinical development for ... Clinical team participation and leadership + Represents Clinical Science on Study Execution and .../ approval of Synopses, Protocols and the conduct of clinical studies . Serves as an advisor to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies . Serves as an advisor or supervisor to other medical directors ... Synopsis / Protocol Development, Study Execution, & Study Interpretation + Oversees all Clinical Science...be accountable for the successful design and interpretation of clinical studies . + Interprets data from an… more
- Takeda Pharmaceuticals (Boston, MA)
- …these activities and is accountable for the successful design and interpretation of clinical studies . Presents study conclusions to Management and determine ... a significant impact on timelines or product labeling. Plans clinical development plans or study designs that.../ approval of synopses, protocols and the conduct of clinical studies . Serves as an advisor to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …these activities, and is accountable for the successful design and interpretation of clinical studies . Presents study conclusions to Management and determine ... **Synopsis / Protocol Development, Study Execution, & Study Interpretation** + Drives clinical science activities...recommendations received into the design of clinical studies / programs as appropriate; accountable to senior… more
- Merck (Columbus, OH)
- …and appropriate resourcing for company internal clinical trial portfolio. + Clinical Research Organization (CRO) Senior , Regional and local Leadership ... CAPAs. **Collaborates and supports:** + Functional Service Provider (FSP) Senior , Regional and local Leadership to ensure...Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and Regional Operations… more
- Abbott (Morgantown, WV)
- …support to EP Sales Representatives in the following areas: + Sales support; + Regional training seminars; + Clinical studies /data collection; + Trouble ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Senior Clinical Specialist** **About Abbott** Abbott is a global healthcare… more
- Vera Therapeutics (Brisbane, CA)
- …Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory aspects of clinical studies in early-to-late development to create high quality ... Title: Senior Manager, Clinical Regulatory Location: Brisbane,...for submission, ensuring complete regulatory content that meets current regional requirements * Represent clinical Regulatory Affairs… more
- Novo Nordisk (Boston, MA)
- …relevant to Rare Renal, and competitive products + Understand the most recent approved clinical studies to educate customers as well as anticipate and (where ... to the cultivation of thought leaders in academic and clinical medicine at local, regional , and national levels + Collaborate with cross-functional partners to… more
- System One (Kansas City, MO)
- Senior Clinical Research Associate - Regional Location: Home Based, Kansas City, MO Type: Full time Start Date: ASAP Are you an experienced Clinical ... in a therapeutically aligned model conducting remote and onsite monitoring of regional sites in a risk-based monitoring model. Responsibilities: + Responsible for… more