- 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
- Ascendis Pharma (Princeton, NJ)
- …mark. We are a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as ... CTS Oncology team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis… more
- Bristol Myers Squibb (Princeton, NJ)
- …to support regulatory filings (as relevant); and developing/maintaining relationships with key clinical trial sites and investigators in the therapeutic area. + ... successful implementation of CAPAs. Leading a multi-national team of clinical trial professionals, who are experts in...of relevant industry experience + Substantial experience of managing senior clinical operations staff in a global… more
- Merck (North Wales, PA)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... and improve lives. **Position Description:** Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist… more
- WuXi AppTec (Plainsboro, 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
- Bristol Myers Squibb (Trenton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager of Biostatistics is a member of cross-functional development ... organizational skills + Ability to: + Learn regulatory requirements & clinical trial design, data analysis and interpretation, + Work successfully within… more
- Bristol Myers Squibb (Princeton, NJ)
- …treatment we pioneer. Join us and make a difference . **Position Summary** The Senior Manager of Biostatistics is a member of cross-functional development teams ... organizational skills + Ability to: - learn regulatory requirements & clinical trial design, data analysis and interpretation, - work successfully within… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …application is true to the best of my knowledge. **Job Description** Senior Manager , Feasibility Are you looking for a patient-focused, innovation-driven ... and empower you to shine? Join us as a Senior Manager , Feasibility based Cambridge, MA or...disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform… more
- Bristol Myers Squibb (Trenton, NJ)
- …related to specified asset(s) in WWM CV & EB. **Key Responsibilities** The Senior Manager of Medical Communications is accountable for the following: Medical ... Professional (CMPP), and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods and clinical trial… more
- Bristol Myers Squibb (Trenton, NJ)
- …towards industry experience + Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical ... and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work… more
- Bristol Myers Squibb (Trenton, NJ)
- …the development and execution of statistical aspects for BMS medical sponsored clinical trials, including contribution to study trial design, analysis planning, ... study results presentation and interpretation, clinical study report authoring and publications. + Provides statistical input on investigator sponsored trials +… more
- Bristol Myers Squibb (Princeton, NJ)
- …Collaborate with the TA Medical Lead, CTL, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the Medical study protocol and ICF, ... in their personal lives. Read more: careers.bms.com/working-with-us . This Senior Director, Medical Evidence Generation (MEG) Lead - Cell...MD preferred, but not required, plus 2-3 years of clinical trial experience, either in industry or… more
- J&J Family of Companies (Trenton, NJ)
- …for presentation at professional meetings. * Stay current with statistical methodology in clinical trial design and analysis. * Know and follow all laws ... Senior Biostatistician - Biosense Webster, Inc. - 2406176946W...will be responsible for designing statistical analysis plans for clinical studies; performing statistical analyses independently; creating reports intended… more
- Merck (Trenton, NJ)
- … Research Associate - Northeast Region (Remote)** With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager , acts as primary site ... site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. +...clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… more
- WCG Clinical (Princeton, NJ)
- …+ Proficient with Excel. + Preferred but not required: + Familiarity with the clinical trial start-up process + Experience reading and interpreting clinical ... skills, and/or abilities required. + Independently redline and negotiate clinical trial agreements for site clients: +...options for resolution of those issues. + Collaborate with Senior Contract Analyst and/or Manager when necessary… more
- Taiho Oncology (Princeton, NJ)
- …team at Taiho Oncology where innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role in ... Sr. Manager , Analytical Development Princeton, NJ, USA Req #362...issues, eg, during process development/validation, manufacturing, and release of clinical trial material. + Contributes to initiatives… more
- Sanofi Group (Trenton, NJ)
- …needs. + In coordination with the R&D Field Medical Lead, oversee MSL support of clinical trial programs. + Manage MSL resources and budgets. + Ensure individual ... Our Medical Affairs function serves as a valued strategic partner with Clinical , Commercial, Regulatory, and Market Access on therapeutic solutions to support… more
