- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to ... WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities to effectively ... scale processes and staff in support of building such data and insight packages.Proactively reaches out and build relationship with key program and study staff at clinical development and operational team levels to drive adoption of fit for purpose strategies… more
- Merck & Co. (Rahway, NJ)
- …for a wide range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial ... Team, Outsourced Trial Team, and Partnerships, Alliances, and Collaborations Team for all project issues related to study budget, site and vendor related payments, asset valuation and impairment.Develop and participate in team presentations associated with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Merck & Co. (Rahway, NJ)
- …Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing queries and follow up ... provide supports SCDM/LCDM in the creation and review of Trial Deliverables, document archiving, UAT of Data Bases, External...operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project - - You… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... 'inspection readiness', identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study reporting.Build… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development ... Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field (clinical trials) required.Advanced… more
- Careerbuilder-US (Cambridge, MA)
- …and other novel technologies. . The CRA, in close partnership with the Clinical Trial Manager has responsibility to assist and support for all study management ... potential and enrolled research participants during conduct of a clinical trial including but not limited to recruitment, screening, informed consent procedures,… more
- Merck & Co. (Rahway, NJ)
- …and external stakeholders (eg, study team, vendors, committees) in support of clinical trial objectives. You will be part of a diverse, cross-functional team of ... the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ProjectYou will partner with CSSM team...critical to the oversight and conduct of a clinical trial . Participate in team meetings to develop an understanding… more
- Novo Nordisk Inc. (WA)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and workstream implementations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Medical & Science Team Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for ... and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director,… more
- Merck & Co. (Irving, TX)
- …CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific ... trials and product development for all our company products. Perform field trial evaluation of newly license products to offer technical support information for… more
- Merck & Co. (North Wales, PA)
- …stakeholders (eg, study team, vendors, committees) in support of clinical trial objectives.Core Skills Working knowledge of clinical research regulatory requirements ... (eg, GCP and ICH)Ability to manage multi e competing priorities with good planning, time management and-prioritization skillsGood understanding of the principles of project planning & project managementBuilding analytical skills to drive operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to close the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure that training ... A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO required. Training &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement initiatives.Qualifications: Successful ... candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree in life sciences or related field (or equivalent experience)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset… more
- Rose International (Pleasanton, CA)
- …a client's business needs and requirements. Possible Contract to hire The Clinical Trial Feasibility Financial Analyst will work with a team under direct supervision ... of the Manager of the Clinical Trials Operations. The specific duties...duties may include: Determine study activities related to clinical trial protocols. Estimate costs related to clinical trial… more
- Merck & Co. (Rahway, NJ)
- …to monitor clinical study data to ensure quality, completeness, and integrity of trial conduct. - Participate in CRF design to ensures data collection is in ... the direction of Lead Clinical Scientist and Lead Study Manager . --Your Fellowship ProjectYou will partner with CSSM team...critical to the oversight and conduct of a clinical trial . Participate in team meetings to develop an understanding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor… more
