- Insmed Incorporated (Bridgewater, NJ)
- …and collecting TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and ... in the review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.Assists… more
- Tris Pharma (Monmouth Junction, NJ)
- … Clinical Trial Management experience in a pharmaceutical, biotechnology, clinical research or related industry in positions of increasing technical and ... manages and supports the clinical operations function by outlining scope of clinical trial programs and aligning resource needs, timelines, cost of services,… more
- Merck & Co. (Rahway, NJ)
- … activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results in areas of ... processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and… more
- Merck & Co. (North Wales, PA)
- …:Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.Develops individual protocols and ... research activities for innovative statistical methods and applications in clinical trial development. Minimum education required: PhD or equivalent degree… more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or equivalent… more
- Merck & Co. (Rahway, NJ)
- … level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager ... Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …local regulations, research process and scientific knowledge as relates to clinical trial conduct through understanding of NN SOP's Demonstrated computer ... business, and other functional groups across NN. External relationships can include clinical trial sites and external vendors. Essential Functions Develop and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Lundbeck (Miami, FL)
- …investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request of Clinical Affairs, assists in clinical trial support by ... in a health sciences related field 5+ years of healthcare or related experience ( clinical practice, research , academic, or managed markets), of which 2+ years… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources...DO, PhD, or PharmD, with 5 years of combined clinical , research or Pharma experience MD, DO… more
- Merck & Co. (North Wales, PA)
- …or related field plus 5 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... or related field plus 3 years SAS programming experience in a clinical trial environment.Department Required Skills and Experience: Effective interpersonal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Merck & Co. (North Wales, PA)
- …or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life ... or related field and at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal skills and ability to… more
- Merck & Co. (Rahway, NJ)
- …biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, ... Relationship ManagementPreferred Skills:Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will ... US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance...schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical ... preferred 4 or More Years with PharmD/PhD preferred Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Principal Scientist position available at its Kenilworth, New Jersey research facility. The Principal Scientist is a senior... research facility. The Principal Scientist is a senior scientific role tasked with working closely with the… more
- Merck & Co. (North Wales, PA)
- …Operations Managers (CQOMs), GDMS, BARDS Statisticians and rest of members of the Clinical Trial Teams (including Country roles) to ensure that systems and ... including conflict resolution expertise and discretion.Preferred: Cross-functional experience in clinical research (eg, monitoring, data management, clinical… more
- Merck & Co. (Rahway, NJ)
- … research , such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, OMOP, ... services to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in biopharma research to support our… more
