- Novo Nordisk Inc. (WA)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects ... and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with multiple… more
- Merck & Co. (Rahway, NJ)
- …and reporting deliverables for global stakeholders in Statistics stakeholders. -The Associate Principal Programmer will gather and interpret user requirements for ... develop tables and figures according to statistical/modeling analysis plan. The Associate Principal Programmer will partner with stakeholders to solve problems;… more
- Merck & Co. (North Wales, PA)
- …field plus 9-12 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment Department Required Skills and Experience: Excellent interpersonal skills and ability… more
- Merck & Co. (Rahway, NJ)
- …team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and deliver on ... and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM) is highly desired. Areas of...and Skills: Minimum 5 years overall experience in Clinical Trial Supply Management (CTSM) and SAP ERP Experience in… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Associate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey SummaryThe Associate Director, Clinical Operations is ... for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug… more
- Merck & Co. (North Wales, PA)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative ... include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a QSP strategy… more
- Merck & Co. (North Wales, PA)
- …clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical/scientific execution of ... clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory… more
- Merck & Co. (Rahway, NJ)
- …Investigator Meetings if requested to.Interface with GCTO partners on clinical trial execution.Escalates site performance issues to CRM and Clinical Research ... within these guidelinesExpertise in and excellent working knowledge of core trial management systems and tools Behavioral Competency Expectations: High emotional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog along with strategy ... of Metrics, KPIs, KRIs and KQIs related to large scale global clinical trial end to end execution. preferredDemonstrated ability to influence at all senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to close the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure that training ... preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, Training &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life ... guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and medical coding expertise to promote best practices across the Clinical Trial lifecycle.Applies GCP principles to ensure all medical coding activities follow ... global SOPs, SOIs, and associate guidelines.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, ... resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize upstream data collection methodologies for faster EDC design… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Target Product Profile (TPP) Development Support: Provide support for clinical trial strategy, regulatory development, and the development of Target Product Profiles ... (TPPs) to ensure alignment with commercialization goals. Gather input from clinical and regulatory teams to understand clinical data / patient outcomes, identify market opportunities, address regulatory requirements, and help to shape product development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may ... CRO scope of work in collaboration with Outsourcing Procurement Management.Lead trial feasibility and site identification activities in collaboration with the CRO… more
- Merck & Co. (North Wales, PA)
- …the biomarker operational aspects of each study.This position will report into the Associate Principal Scientist of Project Management and will be based either at ... to:Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient trial … more
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