- 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
- Merck & Co. (North Wales, PA)
- …of clinical biomarker specimen collection, testing and data delivery activities in clinical studies . The primary focus of this position is in oncology, ... forwardParticipate as a co-author for drafting relevant biomarker sections of clinical study protocolWork closely with Translational Molecular Biomarker (TMB)… 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
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director ( Sr . Principal Scientist) has primary ... The Senior Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting,… 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
- 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
- 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)
- …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
- 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
- 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 ...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… more
- Pfizer (Collegeville, PA)
- …feasibility. **Support study team** + With supervision of medical monitor (director/ Sr director) provides clinical input to protocol/ study team for ... and timeliness of analysis and reporting. + Provides protocol specific training to study team, investigators, clinical research associate , and others. +… 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
- Merck (North Wales, PA)
- …Finance** Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will: + Provide financial ... ** Senior Specialist, Oncology Clinical Development...as well as provide financial support related to assigned clinical studies + Be the primary point of… more
- Merck (West Point, PA)
- …Writing & Communications** Responsible for authoring of clinical protocols, clinical investigator brochures, clinical study reports, regulatory agency ... ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site… more
- University of Pennsylvania (Philadelphia, PA)
- …responsibilities may include scientific leadership of managing and integrating data for clinical trials and observational studies ; assist with grant writing; ... at the University of Pennsylvania seeks candidates for an Associate or Full Professor position in either the non-tenure...services to facilitate the collection, storage, and management of clinical research data for any size research study… more
- Penn Medicine (Radnor, PA)
- …Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn ... each day. Are you living your life's work? Entity: Clinical Practices of the University of Pennsylvania (CPUP) Department:...well as supply information to patients enrolled in these studies . + Schedule follow up studies as… more
