- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is... Manager role is primarily a tactical study delivery role, reporting into an Associate … more
- Merck & Co. (Rahway, NJ)
- …with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the...will collaborate with global, cross functional team members including clinical directors and study managers to lead/support… more
- Novo Nordisk Inc. (WA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Novo Nordisk Inc. (Irvine, CA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Regeneron Pharmaceuticals (Armonk, NY)
- Clinical Study Associate Manager (CSAM)... sites may be required to assist with monitoring clinical studies . **A typical day might include ... trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical...the following:** + Planning and running a clinical study in an assigned region(s) in… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, ... build the organization for the future **Essential Functions:** + Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service… more
- PCI Pharma Services (Bridgewater, MA)
- …customer calls and Clinical Project Team meetings in absence of Project Manager or as designated. + Creates notes for weekly customer teleconference calls and ... pioneer and shape the future of PCI. Supports assigned clinical customer projects to ensure that project goals and...this position. + Performs job duties as assigned by Manager /Supervisor. **QUALIFICATIONS:** + Associate 's degree in a… more
- IQVIA (Raleigh, NC)
- …is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and ... Associate Project Leads are an integral part of clinical trial delivery, liaising with clinical teams...team and/or sub-team. * Accountable for assigned portion of clinical studies as per the contract while… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a **Senior Manager / Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... Lead the planning, design, execution, analysis, and reporting of clinical pharmacology studies (such as food effect,...team strategy + Author and review relevant sections of clinical study protocols, analysis plans, and … more
- IQVIA (Durham, NC)
- …our Clinical Trials Regulatory Management department. **RESPONSIBILITIES** + Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial ... au niveau mondial Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects… more
- Lilly (Indianapolis, IN)
- …areas to support efficiently and effectively exploratory and biopharmaceutics clinical studies . The team will support study development by owning updates to ... successful delivery of the portfolio and clinical trials, the Associate Director/Director Relationship Manager possesses the business acumen, process… more
- System One (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... Role: Clinical Study Associate I...planning and execution of clinical studies ,...issues with the reconciliation to the attention of the Study Manager and propose remediation plan. Distribute… more
- Danaher Corporation (New York, NY)
- …experience as a Clinical Research Associate , Clinical Project Manager , Study Manager or other related professional role. + Fundamental knowledge ... and good understanding of GCPs, clinical trial design, study development and project management. + Experience in interpreting, preparing, writing, and presenting… more
- BeiGene (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required. + Oversees the regional study ... resolution of issues within the region for the assigned study or portfolio of studies . + Contributes... Study Report in collaboration with Global Clinical Study Manager and Medical… more
- Lilly (IN)
- …in the study planning, execution, and close out activities of clinical studies . + Proactively identifies potential technical and operational issues/risks and ... and Analytics colleagues such as the CRF Standards Lead, Clinical Data Manager and other key stakeholders...Data Associate , Clinical Data Management Associate to deliver study database per business… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is... Manager role is primarily a tactical study delivery role, reporting into an Associate … more
- BeiGene (Emeryville, CA)
- …of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing. **Quality** _Line management responsibilities:_ ... _Line management responsibilities:_ + Provides leadership, management, and/or mentorship to associate directors, clinical study managers at various… more
- The Mount Sinai Health System (New York, NY)
- …and plan of the research program. The Clinical Program Manager will report into Associate Director. **RESPONSIBILITIES** Administrative Responsibilities: + ... **JOB DESCRIPTION** The Clinical Program Manager provides clinical...the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart… more
