- 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 ... for study feasibility, and/or study design optimization and/or clinical operations project management preferably with a sponsor company at a global level. Prior… more
- 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)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... processes and functions including experience in one or more clinical trial operations functions / sub-functions (Data Management , Biostatistics, Clinical… more
- Merck & Co. (Rahway, NJ)
- …meetings to develop an understanding of the different skills and expertise of data management within a clinical trial team-- - Benefits of Fellowship - Mentoring ... Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO organization. GDO...the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management skills in a complex, matrix environment including project management preferred- Experience in clinical trial design and improvement activities, ... research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help… more
- Merck & Co. (Rahway, NJ)
- …of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the planning, execution and ... of a global, cross-functional team. You will apply project management , communication, and collaboration skills in support of our...(eg, study team, vendors, committees) in support of clinical trial objectives. You will be part of a diverse,… more
- Novo Nordisk Inc. (WA)
- …Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles ... scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North America… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... in accordance with DS standards. Act as the project manager of the clinical study team to liaise and...kick-off meetings and investigator meetings and training.Note that vendor management is not limited to the CRO, but includes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management .Lead trial feasibility and site identification activities in collaboration with ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Merck & Co. (North Wales, PA)
- …key study planning, development, and execution elements (eg, data management -deliverables, trial level plans/timelines, country/site selection, site materials, ... as part of a global, cross-functional team. You will apply project management , communication, and collaboration skills in-support of our clinical trials. Job… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working knowledge of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to improve organizational efficiencies and cost controls.Communication and Relationship Management - Leads contract related communication with vendors. Respond to ... appropriate utilization and application of advanced negotiation skills, partnership management and strong interpersonal skills to support and advance… more
- Merck & Co. (Rahway, NJ)
- …of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the planning, execution and ... of Protocol and related study materials (eg, ICF documents/amendments, data management deliverables). - May interact with internal and external stakeholders (eg,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop comprehensive ... to close the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure that training… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the ... and execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs ... deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring team in review and interpretation of clinical ... related study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Bristol Myers Squibb (CA)
- …and other relevant instances **Senior Level Expectations :** + Engage with Global Trial Manager , line management and/or Head of Clinical Operations ... met + Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to...required preferably within life sciences or equivalent + Clinical Trial Manager : Minimum of 4 years' industry… more
