- Tris Pharma (Monmouth Junction, NJ)
- … vendor and vendor personnel selection including, but not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, ... opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior ... clinical operations function by outlining scope of clinical trial programs and aligning resource needs,… more
- 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
- Merck & Co. (Rahway, NJ)
- …functional areas and GDMS on cross-functional trial teams and in other trial -level development forums.Under the guidance of more senior staff, may serve as ... data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager...requirements for quality data collection and validation at the trial level.Reads and interprets the clinical protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO...ideally including time in role such as a Global Project Leader at Sr . Director level or… 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 ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… 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 ... Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Merck & Co. (Rahway, NJ)
- …research activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results ... project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are...SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to… 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 ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal… 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
- Merck & Co. (North Wales, PA)
- …with a minimum of five (5) years SAS programming experience in a clinical trial environment.Required Experience and Skills: Experience with study data standards ... external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.-Primary ResponsibilitiesSupporting … 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 ... and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager...other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… 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...Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Aequor (West Chester, PA)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates ... Position Title: Sr . Manager, Global Scientific Communications Pay: /hr Bill:...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… more
- Aequor (Piscataway, NJ)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates ... Job Title: Manager/ Sr . Manager Medical Communications Hybrid schedule: West Chester.PA...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business...strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of… 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 ... processes within the clinical quality framework.Profound knowledge and understanding of clinical development programs, clinical trial processes as well… more
- Merck & Co. (Rahway, NJ)
- …biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, ... to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in biopharma research to support our… more
