- Boehringer Ingelheim (Ridgefield, CT)
- …statistical area(s) of expertise. Concrete application areas may include adaptive clinical trial designs, enrichment designs, aspects of multiplicity, ... on the methodological level. As an international specialist in complex statistical methodology to foster methodological innovation in clinical development at BI,… more
- Rush University Medical Center (Chicago, IL)
- …PM) **Summary:** This position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist research staff within the ... procedures. **Responsibilities:** * Maintain a detailed understanding of Medicare's Clinical Trial Policy (NCD 310.1) and related...items are essential in relation to the aims and methodology of the project as well as meeting the… more
- Novo Nordisk (Plainsboro, NJ)
- …Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other ... NNI skill areas. External relationships include expert advisory board members, investigators, regulators, academic and pharma...community input + Regulatory liaison: + Write and/or review clinical sections of clinical trial … more
- ICON Clinical Research (Salt Lake City, UT)
- … trials, including 2 years in a management role. + Strong understanding of clinical trial design, methodology , and regulatory requirements. + Excellent ... capabilities. **Medical Oversight** + Serve as the primary medical expert for early phase clinical trials, providing...Clinical Practice (GCP) guidelines, and medical ethics standards. ** Clinical Trial Conduct** + Oversee the screening,… more
- Lilly (Indianapolis, IN)
- …external health care professionals according to guidelines above. + Participate in reporting of clinical trial data in Clinical Trial Registry ... where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development **_Clinical Research/ Trial … more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …professionals with the tools, information and services they need to deliver expert medical care. **LOCATION: RTP** **Global Clinical Control & Outsourcing ... project/study financial analysis, and proposal preparation including principles, terminology and methodology . Good knowledge of the Clinical Development process,… more
- AbbVie (North Chicago, IL)
- …to support a global scientific and business strategy. + Extensive knowledge of clinical trial methodology , regulatory and compliance requirements governing ... teams and internal stakeholders. + Serves as the in-house clinical and drug development expert broadly across...+ At least 10 years (12+ years preferred) of clinical trial experience in the pharmaceutical industry,… more
- Pfizer (New Haven, CT)
- …Pharmacology and/or Biomarker Methodology topics and studies. + Act as the expert Physician in Phase 1 clinical research for Worldwide Research and ... SOPs, Work instructions and guidance. + Develops a good working knowledge of clinical trial activities within the industry and passes this on to less experienced… more
- AbbVie (North Chicago, IL)
- …to support a global scientific and business strategy. *Extensive knowledge of clinical trial methodology , regulatory and compliance requirements governing ... cross-functional teams and internal stakeholders. *Serves as the in-house clinical expert for one or more molecules...(eg, MS, PhD) preferred. *At least 10 years of clinical trial experience in the pharmaceutical industry,… more
- AbbVie (North Chicago, IL)
- …to support a global scientific and business strategy. + Extensive knowledge of clinical trial methodology , regulatory and compliance requirements governing ... ADT Leadership Boards (ALBs). + Serves as an in-house clinical expert for one or more molecules...+ At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry,… more
- Sanofi Group (Cambridge, MA)
- …The Clinical Research Director (CRD) is noted as the **primary clinical expert for programs** . The role requires a well-organized, strategic ... + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs...Scientific and medical/ clinical expertise + Expertise in clinical development and methodology of clinical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …communication skills. + Solid knowledge of statistical analysis methodologies, experimental and clinical trial design + Expertise in statistical software such as ... **Director, Biostatistics Early Clinical Development Gene Therapy** The Director of Biostatistics...of Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic… more
- Sanofi Group (Cambridge, MA)
- … clinical feasibility + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, etc.) ... a strong leader. The candidate is considered a "Top-of-Class" expert in the respective therapeutic area (TA). The anti-TL1A...ideally in inflammatory bowel disease + Outstanding expertise in clinical development and methodology of clinical… more
- Philips (Orange, OH)
- …+ You have excellent presentation skills and an ability to effectively communicate clinical trial outcomes to disparate audiences. + You have a minimum ... Clinical Practice (GCP) audits in line with defined methodology . + Planning, coordinating, and executing clinical ...completion of a Lead Auditor Course. + You have expert knowledge of applicable regulations/standards training (ie ICH, ISO… more
- Novo Nordisk (Plainsboro, NJ)
- …and assessment of clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support ... + Assist with identification and support of National Leaders/National Expert Panels for select clinical trials, in...Operations lead + Support investigator meetings + Serve on Clinical Trial Strategy Team in collaboration with… more
- J&J Family of Companies (Horsham, PA)
- …implementation, and analyses and knowledge of meta-analysis as well as epidemiologic studies. + Clinical Trial Methodology : Knowledge of clinical trials ... access needs of the regions as a subject matter expert and advocate for the data necessary for positive...targeted disease states to provide market access inputs into clinical trial design. This includes knowledge of… more
- J&J Family of Companies (Horsham, PA)
- …implementation, and analyses and knowledge of meta-analysis as well as epidemiologic studies. + Clinical Trial Methodology : Knowledge of clinical trials ... access needs of the regions as a subject matter expert and advocate for the data necessary for positive...targeted disease states to provide market access inputs into clinical trial design. This includes knowledge of… more
- Bristol Myers Squibb (Chicago, IL)
- …- Ability to understand and critically appraise scientific publications. + - Knowledge of clinical trial design and methodology , including Good Clinical ... goals + Leverages digital capabilities to enhance medical engagement ** Clinical Trial ** **engagement:** + Provides recommendations and...in a manner that resonates with TLs/HCPs + - Expert knowledge of clinical practice and evolving… more
- AbbVie (Mettawa, IL)
- …to run a complex medical affairs team(s) independently. + Extensive knowledge of clinical trial methodology , regulatory requirements governing clinical ... and/or medical literature. + Manages and conducts Area external expert engagement and may represent AbbVie at external meetings... knowledge in oncology. + Typically, 7 years of clinical trial or medical affairs experience in… more
- AbbVie (Mettawa, IL)
- … study or medical affairs cross-functional team independently. 7. Knowledge of clinical trial methodology , regulatory requirements governing clinical ... experience in the pharmaceutical industry or equivalent. Minimum of 10 years of clinical trial or medical affairs experience in the pharmaceutical industry or… more