- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- J&J Family of Companies (Titusville, NJ)
- …our people can reach their potential. At Johnson & Johnson, we all belong. The Manager , Clinical Trial Leader Project Management (CTPM) is responsible for ... Manager , Clinical Project Manager , Immunology -...Trial Leaders, Clinical Trial Managers, Clinical Trial Assistants, DAS Leaders, Trial Management… more
- Bristol Myers Squibb (Princeton, NJ)
- …Read more: careers.bms.com/working-with-us . Position Title: Executive Director, Global Trial Management , TA Head Immunology/CV Functional Area Description: ... The general manager for all strategic and executional activities within a...This role reports to the Vice President of Global Trial Management (GTM) within Global Development Operations… more
- Ascendis Pharma (Princeton, NJ)
- …a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as an integral member ... team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis Oncology… more
- Taiho Oncology (Princeton, NJ)
- …required. Knowledge, Skills, and Abilities: + 3-5 years of relevant clinical trial management and leadership experience in the pharmaceutical, biotechnology, CRO ... Sr. Study Manager , Clinical Operations Princeton, NJ, USA Req #375...team and study sites. + Responsible for the financial management of the clinical trial in conjunction… more
- Bristol Myers Squibb (Princeton, NJ)
- …trials from study start to database Lock . **Position Summary:** The Senior Manager , Clinical Data Management is a leadership role considered essential to ... member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial , and overall… more
- Merck (North Wales, PA)
- …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
- Edwards Lifesciences (Trenton, NJ)
- ** Manager Biostatistician - Transcatheter Mitral & Tricuspid Therapies (Remote- US)** This is an exciting opportunity for an exceptional biostatistician professional ... order to transform treatment and significantly improve patients' lives. The ** Manager Biostatistician** will represent the Biostatistics department on all aspects of… more
- Bristol Myers Squibb (Princeton, NJ)
- …RCO Clinical Team - Supervise and coordinate the work assignments and performance of Trial Manager , Trial Specialist and Trial Associate staff ... their personal lives. Read more: careers.bms.com/working-with-us . **Title: Senior Manager , Clinical Operations Position** **Responsibilities:** + 7-10 years of… more
