- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the clinical study team are in accordance with DS standards. Act as the project manager of the clinical study team to liaise and coordinate with ... according to the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Merck & Co. (Rahway, NJ)
- …Point of Contact (POC) for assigned protocols and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the ... and or CTT-(as appropriate).Identifies and shares best practices across clinical trials , countries, clusters.-Responsible for collaboration with functional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role will be key to ensure strong monitoring in our clinical trials . Under the oversight of the CRD or Head of Site Management and ... CRM.Attend local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial execution.Escalates site performance issues to CRM and … more
- Merck & Co. (Rahway, NJ)
- …Summary: This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will ... management, communication, and collaboration skills in-support of our clinical trials . Job Responsibilities: - Responsible for...for the operational planning, feasibility, and execution of a clinical trial .- May serve as the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …build 'inspection readiness', identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study ... centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness...of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… 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: ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required- 3+ Years… 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 ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trending to shape the future of Daiichi Sankyo clinical trials .Responsibilities- Process Improvement, Innovation and Optimization (IO):- Project manage GCO ... matrix environment including project management preferred- Experience in clinical trial design and improvement activities, harmonization/optimization, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support drug development processes and global submissions as required for clinical trials . These include developing and validating SAS programs for ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is... clinical trials . This position will work closely… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and...functional areas (eg clinical research & development, clinical science, clinical quality assurance, project… 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)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Hackensack Meridian Health (Hackensack, NJ)
- …mission to transform healthcare and serve as a leader of positive change. The ** Project Manager , Clinical Trials ** develops and implements comprehensive ... project /patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research...Division. **Responsibilities** A day in the life of a ** Project Manager , Clinical Trials… more
- Actalent (New York, NY)
- We have openings for a Project Manager , Clinical Operations with the largest, most comprehensive and integrated health care network in New Jersey, offering a ... center members. + Builds research infrastructure to support multi-center clinical trials . + Performs project ...experience in clinical research. + Experience in clinical protocol and trial document development. +… more
- Weill Cornell Medical College (New York, NY)
- Title: Clinical Research Project Manager Location: Upper East Side Org Unit: Cardiac Research Work Days: Monday-Friday Exemption Status: Exempt Salary Range: ... role when Hired for NYC Offices **Position Summary** The Clinical Research Project Manager supervises...multisite investigator-initiated studies with a focus on large, pragmatic clinical trials . This key role will serve… more
