- 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 ... 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)
- …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)
- …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)
- … clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational studies ; Develop prospective contingency ... biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team ...decision-making process cross-functionally and cross-regionally; Facilitate team coordination. Study Outputs: For Phase 3 studies : Drafts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …profile throughout product lifecycle Independently leads activities without supervision for assigned clinical studies Lead activities under the direction of ... clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… 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
- 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)
- … 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. (North Wales, PA)
- …innovation to:Improve the Clinical Trial experience for our patients.Improve efficiency of study start up by reducing the time from study initiation to first ... accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections,...members including but not limited to scrum masters, technical lead (s) and development team to manage high-quality… 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)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead .Responsibilities:Medical Monitoring Planning (MD Only): For large Phase 2 ... medical content for protocol profile, protocol and amendments for small, uncomplicated clinical studies ; Directs CRO medical monitor activities for Phase 2… 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
- 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
- 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
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... outsourcing of clinical services to Clinical Research Organizations (CROs)...lead recruitment initiatives as required.Accountable for regional outsourcing team deliverables and compliance with global and regional processes.Ensure… more
- Merck & Co. (Rahway, NJ)
- …and Clinical Directors responsible for the design and medical monitoring of clinical studies .Ensure optimal design and monitoring of clinical programs ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team , the Vice President/ Therapeutic Area (TA) Head's primary objectives will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and life cycle management from a medical perspective -Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team , and Global Product… more
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for biomarker development, this ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of...conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study … more
- Aequor (NJ)
- …associated studies , lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate. ... clinical supply strategy in support of global clinical studies , as well as monitoring and...IRT) requirements. Actively participating in Trial Supplies Management Functional team , Study Team , Country Medical… more
