- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …into Sr. Director, Clinical Outsourcing. Under the direction of the Sr. Director, Clinical Outsourcing, the Senior Manager , Clinical Outsourcing will ... qualityMust have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sitesPositive management style,… 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
- 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
- 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
- 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
- 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)
- … 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
- 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
- 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
- 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
- AbbVie (Robbinsville, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS) ... Design Domains + Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer's Guides for both FDA and PMDA submissions + Consult on… more
- Taiho Oncology (Princeton, NJ)
- …complex global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical ... Sr. Study Manager , Clinical Operations...Sr. Study Manager , Clinical Operations Princeton, NJ, USA...trial milestones as well as overall day-to-day operations of clinical studies , ensuring study information… more
- Merck (North Wales, PA)
- …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
- WuXi AppTec (Philadelphia, PA)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... **Essential Job Functions:** + Responsible for all aspects of clinical monitoring and required reporting, including pre- study ...of current developments in Phase I - III oncology studies relative to assigned projects. + Trains and manages… 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)
- …Development + Forecast grant spend as well as provide financial support related to assigned clinical studies + Be the primary point of Finance contact for a wide ... **Job Description** **Position Description:** ** Senior Specialist, Oncology Clinical Development Finance**...stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical … more
- Abbott (Philadelphia, PA)
- …level of all Clinical Specialists in the region. + Acts as a senior clinical interface between the medical community and the business. + Demonstrates ability ... in the following areas: + Sales support + Regional training seminars + Clinical studies /data collection + Trouble Shooting + New product in-service training… more
