- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to ... regulatory agency sponsor inspection with the goal to ensure GCO/ clinical teams are prepared and trained and study...GCO/ clinical teams are prepared and trained and study documentation is quality controlled and available, and all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...in accordance with DS standards. Act as the project manager of the clinical study … 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 ... and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is...quality deliverables. Lead the development of the clinical study plan including critical path activities… more
- Merck & Co. (Rahway, NJ)
- …Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager (LCDM); issuing queries and ... study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of...operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project - - You… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low ... immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design,… more
- Merck & Co. (Rahway, NJ)
- …project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ProjectYou will partner with CSSM team ... of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of...for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG) across functional...cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify… more
- Merck & Co. (Rahway, NJ)
- …project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . --Your Fellowship ProjectYou will partner with CSSM team ... more clinical trials. You will assist the Lead Clinical Scientist and study ... study team with the scientific conduct of clinical studies . In this position, you will… more
- Merck & Co. (Rahway, NJ)
- …in-house, 400+ outsourced or run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials. GCS is accountable for the planning, ... attend educational sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to provide you with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator… more
- Merck & Co. (Rahway, NJ)
- …continuity.The FLEx sterile area supports the formulation and filling of clinical , stability, and developmental supplies for biologics and vaccines, including ... as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development… more
- IQVIA (Bridgewater, NJ)
- …teams to improve patients' lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible for ... clinical delivery of full service, large, multi-regional ...out of scope work. * Work as the primary Clinical Lead alongside other Clinical ...work. * Work as the primary Clinical Lead alongside other Clinical Leads to deliver… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- As a Clinical Study Lead (CSL),...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... NJ or Armonk, NY._ **A typical day as a Clinical Study Lead looks like:**...implement the operational strategic direction and guidance for respective clinical studies + A data driven approach… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Clinical Study Lead ** (CSL)...studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug ... in this role looks like:** + Leads the cross-functional study team responsible for clinical study...implements the operational strategic direction and guidance for respective clinical studies + Demonstrates expert knowledge and… more
- Merck (Rahway, NJ)
- …Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager (LCDM); issuing queries and ... study sites, vendors, committees, etc.) in support of clinical study objectives. You will be part...operational project assignments under the direction of an Operations Manager (OM). **Your Fellowship Project** You will partner with… more
- Taiho Oncology (Princeton, NJ)
- Sr. Study Manager , Clinical Operations...need it most. This is an exciting opportunity to lead clinical studies and experience ... support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring... Manager (SSM) is responsible for ensuring assigned clinical studies are delivered within timelines, budget,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...in accordance with DS standards. Act as the project manager of the clinical study … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Assoc Manager Clinical Study ** (CSAM) role supports the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial ... sites may be required to assist with monitoring clinical studies . **A typical day in this...regular status reports to stakeholders as requested by the Clinical Study Lead + Contributes… more
