- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global ... update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team...initiation, interim and close out visitsExperience as a CRA Manager , Lead CRA or Project ManagerRare disease experienceNOTICE FOR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… 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
- DivIHN Integration Inc (Atlanta, GA)
- …manner. Strong organizational skills and meticulous attention to detail. Familiarity with clinical trial -related and regulatory clinical submission templates ... 224 369 2969 Sivanesan at 224 369 0756 Title: Senior Medical Writing Specialist (REMOTE) Location: Remote Duration: 6...5 years of on-the-job experience in scientific/medical writing (eg, clinical trial and regulatory documents) preferred but… more
- Mindlance (Atlanta, GA)
- …mathematics or related field * Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in ... a project manager , overseeing the statistical and programming aspects of clinical trials from design, through analysis and reporting, acting as the lead… 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
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Senior Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job Profile ... required to enhance clinical research operations. The Senior Clinical Trial Project Manager will independently manage multiple Phase I-Phase II… more
- UCLA Health (Los Angeles, CA)
- …, and other Department leaders and in concert with other research administrative staff, the Senior Fund Manager will be responsible for all phases of pre- and ... post-award administration for intra/extramurally funded research awards for Departmental Principal Investigators (PIs). Analyze problems / issues of diverse scope and determines solutions. You will typically work on complex proposals such as grants / contracts… more
- IQVIA (Durham, NC)
- 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
- Walgreens (Deerfield, IL)
- …Description:** **Job Summary** The Senior Manager Biostatistics will generate Clinical Trial and Real World Evidence (RWE) from various study designs as ... "An Equal Opportunity Employer, including disability/veterans". \#LI-TO1 **Job ID:** 1345491BR **Title:** Senior Biostatistics Manager , RWE Clinical Trials -… more
- Gilead Sciences, Inc. (Seattle, WA)
- …authoring clinical study and regulatory documentation and SOPs. + Meets all requirements for Senior Clinical Trial Manager ( Senior CTM) grade 28 ... Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Clinical Operations is responsible for the worldwide execution of all Phase… more
- University of Maryland, Baltimore (Baltimore, MD)
- …for Health Computing (UM-IHC) is recruiting for a tenure-track physician-scientist with expertise in clinical trial design and execution to serve as Director of ... Clinical Trial Innovation.* The UM-IHC is a...track record of securing independent extramural funding and publishing senior author manuscripts. Qualified candidates are researchers who are… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …Staff Supervisor; Clinical Study and Volunteer Assistant; Volunteer Recruiter; Senior Volunteer Recruiter; Program Manager / Clinical Portfolio Manager ... Regulatory, Clinical , and Technical Clinical Trial...and Social Science Support - Positions may include: Biostatistician; Clinical Data Manager /Regulatory Writer; Quality Assurance Officer;… more
- UCLA Health (Santa Monica, CA)
- Description The Division of Hematology-Oncology is seeking an experienced Senior Clinical Trial Specialist to join our team. In this role you will be ... conduct Site Initiation Visits and Interim Monitoring Visits with clinical trial sponsor representatives; you will also...Nurse Manager , Clinical Research Operations Manager , Investigator, or Senior Management. Assignments may… 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
- Edwards Lifesciences (Sacramento, CA)
- …longer and healthier lives. Join us and be part of our inspiring journey. As the Senior Manager of Clinical Project Management, you will manage complex ... manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables… more
- BeiGene (Emeryville, CA)
- …quality study timelines and tracks progress towards these + Ensures that the clinical studies are operationally feasible, oversees trial feasibility, trial ... Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ) are...evaluation, change control, study closure budget, budget endorsement by senior management + Adheres to clinical study… more
