- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The Manager , Study Associates , under the guidance of the Associate Director, will supervise a group of ... (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Manager , Study Associates will ensure the SAs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies , under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... the Biostatistics, Data Management, and clinical teams.Mentor and train other associates within Data Management, as necessary.Participates in the development of and… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …for some sites in US for a faster FPI in a Global or US only study .Budgets- prepare/review budgets for studies managed in house and review professional fee and ... and vendors, as applicable. Support Functional Head in preparation of annual studies budget and department budget.Manage and track study budget, project… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …every day is important to us.DOWNLOAD OUR CODE OF CONDUCT The Senior Manager , Regulatory Affairs will handle publishing and coordinating tasks for Global RA ... for NDAs, INDs, MAAs, CTAs, 510(k)s, Orphan applications, Pediatric Study Plans, Pediatric Investigational Plans, Fast Track/Breakthrough Therapy Designations,… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager 's Job Title:Head of BDMDepartment Head Title: Associate ... collaboratively with clinical project managers, statistical programmers, clinical research associates , and others to meet project deliverables and timelines for… more
- Taiho Oncology (Princeton, NJ)
- Study Associate I, Clinical Operations Pleasanton,...study team meetings and supports study manager with meeting minutes for assigned studies . ... a dynamic, supportive, collaborative and global cross-functional environment. Position Summary: The Study Associate (SA) I is responsible for operational … more
- University of Pennsylvania (Philadelphia, PA)
- …budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors). The Program Manager will work closely with major ... discipline group meetings, and ongoing protocol training/compliance meetings. The Program Manager will assist in the development/maintenance of study specific… more
- Merck (Trenton, NJ)
- …Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates (CRAs) and to ensure excellent study and site performance with strict ... on Harmonization Good Clinical Practice (ICH GCP.) As line manager , the role is critical to continuously develop key...commitments in a timely manner in coordination with the study CRM. + Attend local Investigator Meetings if requested… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . Medical Project Manager will be responsible for overseeing the conduct of reviews, development, ... and execution of medical evidence generation studies for Cardiovascular as well as be responsible for...the effectiveness of the review of new, evidence generation studies , including ISRs + Oversee tracking and measurement of… more
- Bristol Myers Squibb (Princeton, NJ)
- …design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project ... + Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents… more
- Bristol Myers Squibb (Princeton, NJ)
- …to conduct clinical trials, with accountability of executing these activities from study startup to study closure. **Key Responsibilities and Major Duties** ... + Setting up vendors during study startup period (operational details from sites) + Enter...Organizations, GCP Officer (China only) + Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) Clinical Trial Monitors… more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality control ... for all aspects of clinical monitoring and required reporting, including pre- study visits, site invitation visits, routine monitoring visits (both onsite and… more
- Merck (North Wales, PA)
- …with the Medical Writer on clinical/scientific and regulatory documents. + Partners with Study Manager on study deliverables. + Participates in the ... This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead, you will collaborate with… more
- Bristol Myers Squibb (Princeton, NJ)
- …manager , data manager , PK scientist, and other members of the study /indication team. **Primary Responsibilities** + Core member of an EDT and key sub-teams. ... pioneer. Join us and make a difference. **Purpose** The Associate Director, Biostatistics is a core member of cross-functional...for one or more clinical trials, including contribution to study trial design, analysis planning, study results… more
- Bristol Myers Squibb (Princeton, NJ)
- …of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock . **Position Summary:** The Senior Manager , Clinical ... role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management . This is an...Leadership * Provides clinical data management leadership within the study team to align on and drive data collection… more
- Burlington (Burlington, NJ)
- …every day presents new challenges and opportunities for innovation! As the Manager Industrial Engineering, you'll embark on a journey of engineering and operational ... and effective engineered standards through detailed review of time and frequency studies . Manage the development and maintenance of best practices for all job… more
- Wolters Kluwer (Trenton, NJ)
- …Tax & Accounting North America** is looking for a **Senior Sales Business Retention Associate ** to join our **Research & Learning** team in a remote home office in ... give users unprecedented access to world-class content; **CCH(R) Account Research Manager (R)** , which provides tax and accounting professionals with all essential… more
- Terumo Medical Corporation (Somerset, NJ)
- …Training Manager will evaluate and develop training for all associates , field and non-field facing, within Terumo Interventional Systems (TIS). This role ... and existing associates within TIS. The Professional and Clinical Training Manager is responsible to use the best-in-class means of training delivery including… more
