- Merck & Co. (Rahway, NJ)
- …research portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO ... activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead...an understanding of the different skills and expertise of data management within a clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... RWE and works closely with all colleagues in both the RWE and broader Clinical Data Science & Evidence (CDSE) department. Essential Functions Lead observational… more
- Merck & Co. (Rahway, NJ)
- …Support development of Protocol and related study materials (eg, ICF documents/amendments, data management deliverables). - May interact with internal and ... of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of...close out of clinical trials within a program.- Clinical trials provide the required data which… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies from end to end in collaboration with Physician Scientists and the study team ( data management , clinical operation and other functions) to implement ... position may be at the executive director level or senior director level, depending on the scope and size...in one or several programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to: Global Clinical Operations, Global Regulatory Affairs, Biostatistics and Data Management , Epidemiology, Patient Advocacy, and Global Oncology Medical ... Analysis and Reporting:- Collaborate with the Biostatistics and Data Management (BDM) teams to develop metrics...on diversity metrics in clinical trials- Monitor data and regularly communicate findings to senior … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trials, or academic clinical research background Working knowledge of biostatistics, data management , clinical operations and scientific and technical ... inquiries Lend clinical expertise to the Statistical Analysis Plan development and data management , and work closely with statistical programming and data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management , and Non- clinical Development. Essential Functions ... clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer...in the department General Tasks: Interprets and accurately presents clinical and statistical data in a clear,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, as well as building a network with key staff members including senior management , the global functional leads, Regulatory Intelligence, and Policy and ... external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data on the… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director, Clinical Development. Title and salary commensurate with ... experience. The position is a core member of the Clinical Development management team responsible for developing...(CRO) and/or Medical Writer to contribute to drafting of clinical study reports and other reporting data … more
- Merck & Co. (North Wales, PA)
- …reviewsAssist with review and finalization of all vendor documents such as the safety management , data management , communication, project management and ... Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead...Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of… more
- Merck & Co. (Rahway, NJ)
- …or supporting the QP2-I/O Function Lead on oncology development teams. Data management and analysis.On the job, working with senior scientists you will ... the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to … more
- Merck & Co. (North Wales, PA)
- …team in key study planning, development, and execution elements (eg, data management -deliverables, trial level plans/timelines, country/site selection, site ... management , communication, and collaboration skills in-support of our clinical trials. Job Responsibilities: Responsible for the operational planning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from end to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement ... studies in one or several programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and… more
- Merck & Co. (Rahway, NJ)
- …algorithms; comprehending analysis plans which describe methodologies to be programmed; applying clinical data management concepts; CDISC and ADaM standards; ... 3 years in the following: SAS programming in a clinical trial environment, including data steps, procedures,...programming in a clinical trial environment, including data steps, procedures, SAS/MACRO, SAS/GRAPH, SAS systems and database… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …etc.) preferred Experience Qualifications- 10+ years of previous experience at senior management level leading quality organization and demonstrated track ... team (global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion… more
- Insmed Incorporated (Bridgewater, NJ)
- …will possess a deep understanding of the pharmaceutical development process from pre- clinical development through life-cycle management and be willing to engage ... method development and qualification and laboratory instrument troubleshootingInterpret complex data and solve scientifically challenging problems by providing direction… more
- Insmed Incorporated (Bridgewater, NJ)
- …to contract research organizations. Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on ... teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as ... around rare diseases and immune disorders.Summary The Manager / Senior Manager, Data Programmer is a member... data review listings and reports to support Data Management and clinical teams.Develop,… more
