- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Global Project Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader (GTL), and other members ... Science Strategy and delivery of clinical studies for one or several oncology assets:- Lead...to end in collaboration with Physician Scientists and the study team (data management, clinical … 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
- 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
- Merck & Co. (Rahway, NJ)
- … members. - May interact with internal and external stakeholders (eg, study team , vendors, committees) in support of clinical trial objectives. You will be ... for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary...project assignments under the direction of Lead Clinical Scientist and Lead Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …developing the Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead and manage the multiple late development ... (Oncology) Clinical Science resources are deployed to clinical studies from end to end in...end in collaboration with GCLs, Physician Scientists and the study team (data management, clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities: Study Strategy: Clinical study ... updates; Responsible for valid clinical interpretation of study results as Clinical Study ...KOLs or major institution, eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … operations, responsible for representing the GCO-CQM inspection readiness within the Clinical Team , the inspection preparation team , and transversal ... areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible… more
- Merck & Co. (Rahway, NJ)
- …and execution of one or more clinical trials. You will assist the Lead Clinical Scientist and study team with the scientific conduct of clinical ... for specific clinical /scientific activities on a single study or across multiple studies (eg, medical...project assignments under the direction of Lead Clinical Scientist and Lead Study … 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 externally.The CRM could be responsible for a particular study for several countries in a cluster.Responsibilities include, but...assigned studies : pro-actively plans, drives and-tracks execution and performance of… 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)
- … Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... updates; Responsible for valid clinical interpretation of study results as Clinical Study ...KOLs or major institution, eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SVO to develop/provide input into metrics to help track and oversee the progress of clinical trial risks at both a study and aggregate level to monitor and ... and/or contractor-based) are available to support current and future clinical programs and studies .Drive a feedback-oriented cultureQualifications: Successful… 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)
- …Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead and ... manage GCO Risk Management Plans (RMPs) (design, management, and maintenance) for global clinical trials.Provide day-to-day support to study teams and their line… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cultural sensitivity and health literacy guidelines are followed.Establish tracking mechanisms at the study team and clinical trial site level to proactively ... plans 4) people manage in future. Responsible for the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and ... management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in...of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent… more
- Merck & Co. (Rahway, NJ)
- …to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager (LCDM); issuing queries ... study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of... objectives.--You will be part of a diverse, cross-functional team of individuals who execute our clinical … more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... responsible for guiding Product Development Team Leaders and Clinical Directors within their...projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study… 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
- 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
