- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …as primary point of contact from clinical operations for assigned trials.Oversee study start up activities of CROs (eg Site identification, Feasibility, Site ... selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and...predefined timelines.Prepare and implement Quality control plan in assigned studies and ensure that clinical studies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start -Up activities for PV Safety Operations. This ... clinical study safety reporting and activities.Global Clinical Study Start -Up Documentation: Reviews... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...potential areas of concern and bring to supervisor's attention.Track study metrics such as site start -up, Investigator/site… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to build 'inspection readiness', identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/ ... research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or indirectly support Feasibility and/or additional related areas (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals ... packages.Proactively reaches out and build relationship with key program and study staff at clinical development and operational team levels to drive adoption of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This position supports the strategy for driving global Clinical Study Start -Up activities for PV Safety Operations. This ... study safety reporting and activities. + Global Clinical Study Start -Up Documentation: Reviews... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...areas of concern and bring to supervisor's attention. Track study metrics such as site start -up, Investigator/site… more
- Bristol Myers Squibb (Princeton, NJ)
- …integrity & completeness 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 Data Management is a leadership...not limited to:** Project Management and Leadership * Provides clinical data management leadership within the study … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …functionality. + Monitors and manages clinical supply activities through IRT from study start -up through study closure. + Develops strategy and oversees ... include the following:** + Serves as lead drug supply manager of a program and/or individual studies ...and/or comparator supply strategy. + Develops plans for supplying clinical study sites with ancillary and/or comparator… more
- System One (Princeton, NJ)
- …(CDP). + Provide all necessary leadership and guidance to keep the quality of clinical study -related documents ( clinical study protocol (PRT), ... investigator's brochure (IB), clinical study report (CSR), medical monitoring plan (MMP), safety management...Minimum 10 years of experience in planning/developing, and managing clinical studies within the pharmaceutical industry. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) Clinical Trial Monitors (CTMos), Study Start -up Specialists, Site Contract ... key internal matrix relationships and key external stakeholders/clients + External: Clinical Study Sites, Institutional Review Boards/Ethics Committees, Vendors,… more
- Vitalief (New Brunswick, NJ)
- …with sponsors, interfacing with various internal departments as needed. + Facilitates clinical trial billing administrative start -up, insuring clinical ... are expanding our footprint rapidly as a value-add, innovative Healthcare, Research and Clinical Trials Consulting Company. As a result, we are seeking talented and… more
- System One (Raritan, NJ)
- Title: Manager , Global Medical Affairs Strategy and Execution (Publications) Location: Must be local Raritan, NJ and required to go onsite 2-3 days a week Type: ... Embedded Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Manager , Global Medical Affairs Strategy and Execution w/ 5+ years industry… more
- Bristol Myers Squibb (Princeton, NJ)
- …trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications. + ... manager , data manager , PK scientist, and other members of the study /indication team. **Primary Responsibilities** + Core member of an EDT and key sub-teams.… more
- Lilly (Branchburg, NJ)
- …for daily biologics manufacturing operations and for the specification, installation, start -up and validation support of process equipment projects. As applicable, ... PLCs, HMIs, OSI PI Historian OSI PI historian, MS SQL reporting, Thin Manager , data analytics tools (Tableau, Power BI, etc.), as applicable. + Professional… more
