- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(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
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …Director, Clinical Outsourcing. Under the direction of the Sr . Director, Clinical Outsourcing, the Senior Manager , Clinical Outsourcing will lead ... with a focus on dermatology, ophthalmology and onco-dermatology. Description: Sun is seeking a Sr . Manager , Clinical Outsourcing within its 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …metrics, and provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in ... who assist in planning and in the execution of clinical studies in adherence to the protocol,...International Conference on Harmonization (ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical… 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
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- … Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager 's Job Title:Head of BDMDepartment Head Title:Associate VPDoes ... responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating collaboration… 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities ... of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.Responsibilities:Protocol...areas from Phase I through life cycle management. Briefs senior management on assigned projects or studies … more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Job Title: Head of Clinical Data Management Job Grade: G6/G7 Department: Biostatistics and Data Management FLSA Classification: Manager 's Job Title: Head of BDM ... responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating collaboration… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Manager , Biostatistics This position reports to...on day to day support of one or more clinical studies . The position will provide oversight of ... research. Responsibilities:Serve as the statistical lead on one or more clinical studies in different phases of developmentEngage in planning, methodology,… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Manager , Sales Training, Biologics Sun Pharma, Princeton, New Jersey The Sales Training Manager is primarily responsible for the successful ... some of the following)* Prepare all required training materials and/or home study materials necessary for initial and follow-up training classes* Oversee the… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Manager , Biostatistics This position reports to...on day to day support of one or more clinical studies . The position will provide oversight of ... Serve as the statistical lead on one or more clinical studies in different phases of development...report forms (CRFs), data management plans, data specifications and clinical study reports, creation of randomization schedules,… more
- Taiho Oncology (Princeton, NJ)
- Sr . Study Manager , Clinical Operations...to support the Clinical Development Plan. The Senior Study Manager (SSM) is ... and monitor trial milestones as well as overall day-to-day operations of clinical studies , ensuring study information and timelines are accurate in internal… more
- Bristol Myers Squibb (Princeton, NJ)
- … trials from study start to database Lock . **Position Summary:** The Senior Manager , Clinical Data Management is a leadership role considered essential ... 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
- 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
- Merck (North Wales, PA)
- …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
- Merck (West Point, PA)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates ... strategic and operational plans associated with the downstream activities of clinical supplies for their assigned studies . The primary function of the IM CSPM is… more
- University of Pennsylvania (Philadelphia, PA)
- …manage a portfolio of Phase I Penn-Sponsored clinical research studies . The Sr . Clinical Project Manager is responsible for the overall execution and ... study close/database lock. Core functional responsibilities of the Sr . Clinical Trials Project Manager ... clinical trial processes, and the conduct of clinical studies . Reference Information: The salary range… 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
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Senior Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job ... required to enhance clinical research operations. The Senior Clinical Trial Project Manager ... clinical research and oversee clinical studies from concept to final close, including study… more
