- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Job Title:Head of Clinical Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager's Job Title:Head of BDMDepartment ... Head Title: Associate VPDoes This Position Have Any Direct Reports?YesJob Description...will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating… 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 ... Department Head Title: Associate VP Does This Position Have Any Direct Reports?...will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating… 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 ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... documentsServes as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role... Associate Director (or above) responsible for Operational Study Strategy. This position may require the Sr… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associates, under the guidance of the Associate Director, will supervise a group of Study Associates (SAs) or Senior SAs who assist in planning and in the ... execution of clinical studies in adherence to the protocol,...provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...you ready to make a difference? The Position The Associate Director, Research Partnerships (RP) is responsible for developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, ... Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indications.Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document ... research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …KPIs, KRIs, KQIs across all RD LFs. Define Cycle Times, Identity key milestones at Study , Country, and Site Level to gauge clinical trial performance. Build and ... and roles. Candidate will be responsible for managing external Benchmarking Study Submissions and seeking out external competitive intelligence to provide line… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements for diagnostics and devices.Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, ... dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker,… more
- WuXi AppTec (Plainsboro, NJ)
- **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 ...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… 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 ... project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). **Responsibilities** - Reconcile the TMF… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …define ancillary and/or comparator supply strategy. + Develops plans for supplying clinical study sites with ancillary and/or comparator supplies, either through ... The ** Sr Manager, Clinical Drug Supply &...master kit lists. + Designs, reviews, and approves IP-related study tools (for clinical study … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... + Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD and Pop… more
- Bristol Myers Squibb (Princeton, NJ)
- …integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock . **Position Summary:** The ... Senior Manager, Clinical Data Management is a...R&D pipeline . This role may report into Director, Clinical Data Management or Associate Director, … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy:… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and sourcing strategies at the asset, program, and study levels for Regeneron clinical trials. The associate director will be part of a team that drive ... The Associate Director of Comparator Strategy and Operations is...external stakeholders, including Global Development, Regulatory, Industrial Operations, and Clinical Finance to develop and drive the implementation of… more
- Kelly Services (Raritan, NJ)
- Kelly Services is currently seeking a ** Senior Clinical Project Scientist** ( Associate Director) for a long-term engagement with one of our Global ... vacation, and sick/personal time. **PRINCIPAL RESPONSIBILITIES:** + Partners with Study Responsible Physician SRP to provide clinical ...with Study Responsible Physician SRP to provide clinical oversight to the study . + Develops… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . ** Sr . Principal Scientist DMPK Project Representative** Challenging. Meaningful. Life-changing. ... and PK (pharmacokinetics) support for all pipeline assets throughout clinical development, from candidate nomination through registration and lifecycle management.… more
