- Abbott (South Portland, ME)
- …objectives and financial targets. + Lead the strategic execution of complex global clinical IVD trials for the Rapid Diagnostics Infectious Disease business ... + Responsible for understanding and application of Global regulatory requirements related to IVD clinical studies and accountable for complying with all relevant… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- The Senior Project Manager (Sr.PM), Clinical Affairs (CA) Microbiology Portfolio will manage a suite of clinical projects focused on the Microbiology ... gain trust of CA functional stakeholders and leadership team. + Set and lead Clinical Affairs project team meetings independently, assist others in running … more
- Hologic (San Diego, CA)
- Sr Manager , Clinical Compliance San Diego, CA,...US and EU regulations relevant to Medical Device and IVD clinical trials and Quality Systems, including ... United States **Job Summary** As the Senior Manager of Clinical Compliance, you will play...research. + Experience in an in vitro diagnostic device ( IVD ) environment is highly preferred.Strong knowledge of relevant international… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …communication to align stakeholders and track goals/milestones. + Run Clinical Affairs project meeting when project manager (s) is unavailable. + Present ... Project Coordinator II (PCII), Clinical Affairs...-related updates to large groups. + Share ownership of project -related tasks with project manager (s),… more
- TE Connectivity (Boston, MA)
- …Americas Sales/Account Manager (SAM) is responsible for promoting the TE IVD Business Unit products and services. This position is responsible for developing and ... range of IVD Services, Products and Core Competencies. The Sales/Account Manager serves as the primary interface with customers while collaborating with internal… more
- ThermoFisher Scientific (Cincinnati, OH)
- …Design History File (DHF) project . + Interact as the primary clinical studies representative to Pharmaceutical partners concerning IVD study requirements. + ... role, the primary responsibilities include: + Participate as a clinical study representative for project core teams. + Participate in lab assessment visits and… more
- Abbott (South Portland, ME)
- …on site out of our **South** **Portland, Maine** location. The position of ** Manager ,** ** Clinical Quality and Compliance** s within our **Infectious Disease** ... business unit. In this role, the Manager of Clinical Quality and Compliance will...Practice (GCP) and/or Quality Assurance Environment, including 5+ years clinical study/ project management experience + Broad knowledge… more
- Danaher Corporation (New Brighton, MN)
- …with diagnostic tools that address the world's biggest health challenges. The Sr. Clinical Affairs Manager is responsible for directly managing a team driving ... protocol/amendment(s), SOPs, GCP, PHI, and applicable regulatory requirements + Drive clinical schedule deliverables and project financial forecasts to meet… more
- Danaher Corporation (Chaska, MN)
- …to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials. If you thrive in a cross-functional, detail-oriented role and ... clinical study samples. + May perform other clinical project activities such as drafting documents,...sciences or related field required with 5+ years of clinical trial experience in vitro diagnostics ( IVD ),… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …development pipeline in close partnership with Diagnostic Strategy Leads and IVD Regulatory. This role includes portfolio management, program/ project management ... The role of Senior Manager , Diagnostics Program Management & Operational Delivery, is...and studies with close collaboration to CDx Strategy Leads, clinical laboratory managers, IVD regulatory and others… more
- Bio-Techne (Minneapolis, MN)
- …and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers ... disease worldwide. Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing,… more
- ThermoFisher Scientific (Middletown, VA)
- …of IVD products focused on Immunological Assays, Biologicals and Clinical Chemistries (reagents, calibrators, diluents, bulks, controls) used in clinical ... day in the Life:** Make an impact! The Sr. Manager , Validation Engineering is a key part of the...systems and recommend level of validation required + Coordinated project management activities for validation projects are within scope… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Manager External Data Management, is accountable for an end-to-end delivery of ... External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety,… more
- Danaher Corporation (Miami, FL)
- …will work within the Systems Engineering team and report to the Senior Manager of Systems and Hardware, New Product Development responsible for leading design tasks ... integrating these systems, along with reagents and algorithms, into world-class clinical diagnostics analyzers. If you thrive in an amazing, innovation-oriented,… more
- Bio-Techne (Devens, MA)
- …and point-of-care testing, along with custom products to other companies serving the IVD market. The Program Manager is responsible for building and maintaining ... and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers… more
- Danaher Corporation (Miami, FL)
- …member of the R&D Hardware team, this role will report to the Manager , Systems Engineering responsible for development and sustaining of in vitro diagnostic ... and customer driven product improvements + Supports and actively participates during project phase reviews, Risk analysis, DFMEA, PFMEA + Executes studies, performs… more