- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...activities in collaboration with the CRO and the study team . Oversee the site qualification process.Monitor clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …point into the Clinical Data Science and Evidence (CDSE) Real World Evidence (RWE) team . Relationships The Senior Manager reports directly to a Senior ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Merck & Co. (North Wales, PA)
- … team .Job Responsibilities: Responsible for leading specific aspects of clinical /scientific execution of clinical protocol(s). This may include:Serving as ... the lead clinical scientist on a clinical trial team .Leading medical monitoring team...study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection… more
- Merck & Co. (Rahway, NJ)
- …executing end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager ... study objectives.--You will be part of a diverse, cross-functional team of individuals who execute our clinical ...Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior level… more
- Merck & Co. (North Wales, PA)
- …operational planning, feasibility, and execution of a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, ... resolution.May facilitate and collaborate with key internal/external stakeholders (eg, study team , country-teams, vendors, committees) in support of clinical … more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... Standard Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of… more
- Merck & Co. (Rahway, NJ)
- …and execution of one or more clinical trials. You will assist the Lead Clinical Scientist and study team with the scientific conduct of clinical studies. ... protocol. You will be part of a diverse, cross-functional team of individuals who execute our clinical ...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities ... supporting the vaccine expansion facility. Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of all activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to ... contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; works closely with statistical programmers… more
- Merck & Co. (Rahway, NJ)
- …team members. - May interact with internal 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 individuals who execute our clinical ...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in ... senior management special projects, corporate task forces, department team evaluations and interview programs; large cross functional training projects (eg… more
- Insmed Incorporated (Bridgewater, NJ)
- …do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the ... 2022, and 2023Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating...drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, ... execution of a communication plan (and related campaigns) supporting the team 's annual and periodic Training objectives.Prepare reports, presentations, and related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's ... the candidate will have to lead a complex, global team in charge of a global clinical ...proactively regular strategic and tactical status updates to their manager and governance on progress, risks, opportunities and challenges,… more
- Novo Nordisk Inc. (Durham, NC)
- …technology & processes in accordance with relevant project plans & timelines. Relationships Senior Manager , Quality Control - OFP. Essential Functions Accuracy & ... career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters....minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory May consider a High School… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical ... This position is accountable for partnering with the Global Team leader as the Project Management lead on drug...and to drive the development and delivery of the clinical development plan in alignment with the product development… more
- Novo Nordisk Inc. (Poughkeepsie, NY)
- …only 2% of them receive dedicated medical treatment. By joining the Obesity Commercial team , you will have the opportunity to help people with obesity receive the ... recognized as a chronic disease and to reduce barriers to treatment. Our team is the company's obesity strategy anchor, partnering enterprise-wide to deliver on this… more
- Novo Nordisk Inc. (Minneapolis, MN)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... Position To provide area leadership and supervision to the field Market Access team and to develop and implement Market Access strategies that increase profitability… more
