- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a project manager for other activities involving assigned product(s) or clinical studies, as needed Qualifications: Successful candidates will be able to meet ... This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops ... Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical administrative support to the study teams and support interactions with the ... and provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in departmental and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs).Oversee and ... operational aspects of phase I-IV US based or global clinical trialsAct as primary point of contact for internal...contract review. Act as primary point of contact from clinical operations for assigned trials.Oversee study start up activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... and trending to shape the future of Daiichi Sankyo clinical trials.Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project manage GCO… more
- Merck & Co. (North Wales, PA)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …current co-promotion partners. Internally, the VSR reports to the Virtual Sales Business Manager . The VSR also interacts and collaborates on a regular basis with ... and support staff to drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Develops and sustains… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ResponsibilitiesSafety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. SummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and creation ... Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending best… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility ... if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses ... in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... coaching for progressive skills development; Assessing and training product knowledge and clinical selling; Teaching and coaching managed care overview, as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
