- Merck & Co. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned ... Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE)...Research Manager (CRM) could be responsible for a particular study for several countries in a cluster.Responsibilities include, but… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or project; Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational ... biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team ...Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies … more
- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site ... quality deliverables. Lead the development of the clinical study plan including critical path activities...CRO and vendor selection process in collaboration with the study team and outsourcing procurement management. Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies from end to end in collaboration with GCLs, Physician Scientists and the study team (data management, clinical operation and other functions) to ... site scientific engagement, and HA responsesInteractions with the internal clinical study physicians and physician scientists as...Global Clinical Science Strategy and delivery of clinical studies in late stage developmentLead and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …resolve, propose solutions, or bring to the attention of the operations lead of study team lead . Coordinate and liaise with Daiichi Sankyo QA on site ... and quality deliverables. Lead the development of the clinical study plan including critical path activities...CRO and vendor selection process in collaboration with the study team and outsourcing procurement management. Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team ... the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities Study Strategy: Drafts...and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO;… more
- Eisai, Inc (Nutley, NJ)
- …GV&A projects related to both clinical trial setting and observational studies .Serve as the lead statistician on project teams, offer statistical insights ... crucial role within the Global Value & Access (GV&A) team , responsible for leading and overseeing statistical activities across... clinical trial data, patient registries, and observational studies ) to support study design and otcomes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Merck & Co. (Rahway, NJ)
- …simultaneously. Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world...submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …improvement opportunities.Communicate and reinforce content and interpretation of Daiichi Sankyo's Clinical Data Standards to DS Project and Study teams, ... CDR, EDC) thereby developing optimal approaches to support the collection of diverse clinical data.Participate in data standards team meetings and provide input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... all aspects of clinical pharmacology and biopharmaceutics studies ; clinical pharmacology project lead ;...interactions at project level, interacts with regional and global study and project team members, and to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team , providing the safety leadership ... Clinical Safety, will be a product safety lead or part of a product safety team...and provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and… more
- Merck & Co. (Rahway, NJ)
- …authoring for regulatory documents such as Investigational New Drug application, Clinical Study Report, Common Technical Document, and agency- interactions.-You ... and Pharmacometrics --Immune/Oncology-(QP2-IO)- team in the role of-Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the medical coding activities and deliverables. Ensures deliverables meet/exceed project/ study team expectations regarding quality, time, and cost.Establishes ... Functional Expertise:Serves as a subject matter expert in medical codingReviews/approves clinical study related documents pertaining to medical coding and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Insmed Incorporated (Bridgewater, NJ)
- … studies and provide clinical pharmacology support to late phase clinical studies Plan, perform, and/or oversee PK, PK/PD and pharmacometric analyses for ... to support clinical dose and dosing regimen selection, facilitate clinical study design and support regulatory submissionsAuthor regulatory summary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant regulatory requirements. This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry ... Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/ study team expectations regarding quality, time, and cost… more
- Eisai, Inc (Nutley, NJ)
- …illness, etc.) as well as the potential for observational health economic studies (prospective or retrospective study of cost and/or outcomes).Conduct systematic ... integral member of the Global Value & Access (GV&A) team and is responsible for the design and implementation...disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of… more
