- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
- Tris Pharma (Monmouth Junction, NJ)
- …and other existing/investigational products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and ... facility for an experienced MD to serve as Senior Director or Director , Clinical Development....by working closely with local functions on the full clinical trial life cycle; Reviews, synthesizes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, ... identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial ...data activities required7 or more years experience in Oncology trials with an understanding of the complex and interdependent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serving as the primary point of contact.- Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs).Oversee ... Director , Clinical Operations/CPMSun Pharma Advanced Research...QualificationBachelor of Science in a life sciences discipline, or higher qualification Experience10+ years of Clinical trial … more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- … Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as ... Associate Director , Clinical Operations Sun Pharma Advanced...bid-defense process under guidance and supervisionEducation and QualificationBachelor degree in life sciencesExperience7-10 years of Clinical trial … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... National Leaders/National Expert Panels for select clinical trials , in collaboration with Clinical Director... Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the ... clinical development strategies for investigational or marketed Oncology drugs-Planning clinical trials (design, operational plans, settings) based on these … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Voice Strategy and Infrastructure.Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development (ie. Patient voice) ... vendors, or investigative sites on the importance of representative diversity in clinical trials and patient voice.Identify innovative approaches, industry best… more
- Merck & Co. (Rahway, NJ)
- …and SAP team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and ... Management and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM) is highly...support of- SAP applications across all functional areas supporting Clinical Trials . This includes leading or contributing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical /regulatory documents Authors, reviews and/or edits documents to support clinical trials and regulatory submissions, which may include: Clinical ... medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA),… more
- Insmed Incorporated (San Diego, CA)
- … at a Sponsor company.Experience managing various phases of clinical trials .Experience in global clinical trial conduct across several therapeutic ... development of systems, practices, and procedures to ensure efficient and effective clinical trial execution including data management and analysis.Build and… more
- Merck & Co. (Rahway, NJ)
- …monitoring in our clinical trials . Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person ... clinical trial execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage CRA - career… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …the Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, ... role will be Instrumental in the management of external partnership outcomes for clinical trials , including coordination and management of service providers and… more
- Merck & Co. (Rahway, NJ)
- …stakeholders including the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team, Outsourced Trial ... Clinical Development Finance Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior Specialist will:Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage...strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology… more
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