- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager...assigned, Sr . CSM may act as the Study Team Leader for the assigned clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the… more
- Merck & Co. (Rahway, NJ)
- …executing end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager ... study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of...Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior level… 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)
- …progressive on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ... for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary...& networking opportunities within and beyond CSSM Exposure to Senior level positions within the clinical development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Merck & Co. (Rahway, NJ)
- …Lead Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your ... for specific clinical /scientific activities on a single study or across multiple studies (eg, medical...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the ... The Senior Manager Clinical Scientist Hematology...and interpretation of study data of a clinical development program. The Sr . Manager … more
- Bristol Myers Squibb (Madison, NJ)
- …from study start to database Lock . **Position Summary / Objective** The Senior Manager , Clinical Data Management is a leadership role considered ... not limited to:** Project Management and Leadership * Provides clinical data management leadership within the study ...and written communication skill s + Communicate effectively with senior management and cross-functional teams + K nowledge of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …necessary to design and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a typical day may include the ... The Senior Manager , Hematology, Clinical Scientist...and interpretation of study data of a clinical development program. The Sr . Manager … more
- Bausch Health (Bridgewater, NJ)
- … pharmacokinetic/pharmacodynamic (PK/PD) studies . + The individual will work with clinical pharmacology and R&D senior staff on early and late-stage ... with our health care products. JOB DESCRIPTION + The clinical pharmacology manager will support the design,... studies and regulatory submissions. * Represent the clinical pharmacology function in multi-disciplinary study teams… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... SOPs. + Meets all requirements for Senior Clinical Trial Manager (... studies . + Proven ability to effectively author clinical study and regulatory documentation. + Ability… more
- Merck (Rahway, NJ)
- …executing end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager ... study sites, vendors, committees, etc.) in support of clinical study objectives. You will be part...Fellowship** . Mentoring & networking opportunities within and beyond Clinical Trial Operations . Exposure to Senior … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Senior Clinical Study Lead**...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
- Boehringer Ingelheim (New Brunswick, NJ)
- …the procurement and sourcing strategy for the local categories with exposure to Clinical Studies and/or Non-Interventional Studies . This role will also ... issues at an early stage. + Provide feedback to ( Senior ) Category Manager as needed. + Manage...digital therapies preferred + Familiarity with and exposure to Clinical studies and/or Non-Interventional Studies … more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Sr Manager , Clinical Drug Supply...as needed. + Compiles and reports supply status to study teams and senior management + Applies knowledge ... include the following:** + Serves as lead drug supply manager of a program and/or individual studies ...and/or comparator supply strategy. + Develops plans for supplying clinical study sites with ancillary and/or comparator… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). **Responsibilities** -… more
- J&J Family of Companies (Skillman, NJ)
- Sr Scientist SH Claims Clinical -...for protocols and digital methodologies supporting in vitro and clinical studies for new products. + Serve ... 2407021764W **Description** Kenvue is currently recruiting for: ** Senior Scientist, Skin Health Clinical Research &...Director and fulfill the responsibilities for this role on clinical studies + Participate in the development… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …complex assignments that enable multiple functions and teams to achieve their clinical study objectives within targeted timelines and allocated resource levels. ... team members in solving problems. Depending on business need, may manage Clinical Project Assistant/ Clinical Trial Management Assistant/ Sr . Clinical… more