- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) ... in the pharmaceutical industry (Pharma/Biotech/CRO) Previous experience leading cross-function clinical trial operations teams preferred Expert in ICH-GCP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... efficiency and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve business… more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
- Bausch Health (Bridgewater, NJ)
- …for Clinical Operations. May supervise direct/indirect reports including Clinical Trial Manager (CTM), Senior Clinical Research Associates and ... Clinical Research Associates (Sr. CRAs and CRAs) and Clinical Trial Assistants (CTA).. **Responsibilities** + Manage...are being met and provide the operations director and/or senior management with timely updates on progress and changes… more
- Vitalief (New Brunswick, NJ)
- …is carried out as outlined. + Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active ... is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities. + Performs prospective reimbursement analysis according… more
- Vitalief (New Brunswick, NJ)
- …Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions. Reasons to Work for Vitalief: + ... patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management. and other clinical trial activities for solid tumor, high… more
- WuXi AppTec (Cranbury, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and WuXi Clinical Standard Operating… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Senior Study Manager - Cardiometabolic** Our Clinical Research and Pharmacovigilance team push the boundaries ... update reports, study closeout activities). May serve as the clinical trial team (CTT) lead. Leads team...and close out visits + Experience as a CRA Manager , Lead CRA or Project Manager +… more
- Merck (Rahway, NJ)
- …**Job Responsibilities** + Responsible for the operational planning, feasibility, and execution of a clinical trial . + May serve as the clinical trial ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck (Rahway, NJ)
- …development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the ... Overview: Under the direction of the applicable management, the Clinical Data Manager (CDM) is responsible for...Senior /Lead CDM (SCDM/LCDM). + Runs data integrity check reports… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Senior Manager , Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on ... ICH, and National regulations). **ROLE RESPONSIBILITIES** + Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …analysis plans (SAPs). + Oversee strategy and support operational aspects of clinical trial execution, data management and data analysis in partnership ... large pharmaceutical companies, including a strong background in rare disease development and clinical trial design including pediatric programs. + Minimum of 5… more
- Pfizer (New York, NY)
- …with internal/external stakeholders. + Advanced knowledge, experience and expertise in clinical trial development, and operational quality management disciplines ... + Responsible for ensuring Level 1 GCP quality for clinical development programs within Pfizer Oncology R&D by establishing...Location:On Premise / Hybrid + This is a people manager role + Last date to apply is June… more
- Publicis Groupe (New York, NY)
- …you join a tight-knit community of award-winning creative directors and clinical trial designers, accomplished data-scientists and media specialists, behavioral ... with focus, energy and passion. + Work closely with your art director, manager , and other departments to ensure that projects are completed on time.… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …Over time, the candidate is expected to progress to support statistical sections of clinical trial protocols and also for development of the statistical analysis ... support for developing statistical analysis plans for early and late-stage clinical trials, providing statistical support for medical affairs publication and… more
- Actalent (New York, NY)
- …IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process Education: Level of education preferred (if ... as applicable for the projects with input provided by senior staff * With guidance from line manager...Out-of-Scope or over burn with the support of more senior specialists Skills: Contract, clinical research, contracts,… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- … clinical , and scientific excellence, talent acquisition and retention, the clinical trial portfolio, grant funding, professional development, mentorship and ... of MSK's senior leaders to support the full spectrum of clinical care, training and transdisciplinary research in Hematologic Malignancies. The Division Head… more
