- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... the global clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and reporting on … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …term experiments to advance clinical development. ResponsibilitiesServe as QCP representative on Clinical studies or take a lead on Clinical pharmacology ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… 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...engagements. This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and… more
- Novo Nordisk Inc. (San Francisco, CA)
- …relevant to Rare Renal, and competitive products Understand the most recent approved clinical studies to educate customers as well as anticipate and (where ... and academic and community thought-leaders in an assigned territory. The Rare Renal Clinical Account Manager will be principally responsible for driving disease… more
- Merck & Co. (Upper Gwynedd, PA)
- …management duties supporting one or more clinical trials. Under the oversight of a clinical scientist, study manager , or program lead, the Clinical ... external stakeholders (eg, study sites, committees) in support of clinical trial objectivesCore SkillsPharmaceutical, research , medical, and/or clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, ... for performing near real-time biosample tracking for the assigned studies in close collaboration with the QCP, Clinical...QCP, Clinical Biomarker Team, Companion Diagnostics, the Clinical Study Teams, Central & Specialty Laboratories,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …conduct of Interventional, Non-interventional, Managed Access Programs, Investigator initiated studies and Collaborative Research .Support adherence to regulatory ... studies , Compassionate Use or Managed Access Programs, Investigator initiated studies and Collaborative Research to include timely escalation of Quality… more
- Eisai, Inc (NJ)
- …change orders, and contract closeout. Drives the contracting process between clinical study teams and service providers (initiation, negotiation, execution, ... research organization or other relevant providers. Knowledge of clinical research process and regulatory environment Demonstrates business/financial for… 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 ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose ... financial reconciliation and negotiation of Vendor contracts prior to study termination and contract closure. Manages all aspects of...to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services… more
- Eisai, Inc (Nutley, NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan Ministry of Health, Labor… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …strategic/tactical planning and execution activitiesDirect participation in pre- clinical and clinical research studies at multiple campuses within ... Research Institute (LBRI), is currently seeking a Program Manager for Dr. Mayer's lab. The successful applicant will...a minimum of 5+ years of directly-related expertise in research studies and administration; or an equivalent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary NOTE: This ... Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling...position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role as… more
- Aequor (Thousand Oaks, CA)
- …report writing to inform design and apply sound HFE/UE knowledge and experience to research , development, clinical studies , product validation in support of ... zone. May be travel required to travel to different research centers. Up to 1 week per month. Ideal...with pre filled syringes 20% and 80% auto injectors. Manager would like to see writing samples if available.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …direct implications for account team planning and implementation. Entails coordinating market research and development of access and ARP scenarios to ensure launch ... scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making Assesses investments in payer… more
