- Nuvance Health (Danbury, CT)
- *Description* * Clinical Research Regulatory and Operations Coordinator Investigator* *Full-time, 40 hours, Monday - Friday, 8:30 am - 5:00 pm* *Summary:* ... tracking. Manages submissions to the Institutional Review Board (IRB) Performs additional non- clinical clinical research coordinator duties (eg data… more
- Cardinal Health (Hartford, CT)
- …role involves providing strategic regulatory support across the lifecycle of clinical research , development of clinical development plans, development of ... **_What Regulatory Affairs and Clinical Submissions contributes...marketing applications. + **Cross-functional Collaboration** + Work closely with clinical operations , project management, medical affairs, legal,… more
- Takeda Pharmaceuticals (Hartford, CT)
- …Interns will have the opportunity to partner with the others business units ( Clinical Operations , Regulatory , Legal, Field Medical, R&D Health Equity, ... & Engagement in the following departments: **Diversity, Equity & Inclusion in Clinical Research ** + Support the development of a global diversity strategy + Data… more
- Takeda Pharmaceuticals (Hartford, CT)
- …area is advantageous. + Knowledge in global regulatory and compliance requirements for clinical research , including but not limited to US CFR, EU CTD, and ... and empower you to shine? Join us as a Clinical Operations Manager based remotely reporting to...5 or more years' experience in pharmaceutical industry and/or clinical research organization, including 3 or more… more
- Sumitomo Pharma (Hartford, CT)
- …for FDA meetings) and responses to HA information requests and interacts with Regulatory Operations to submit electronically + Represents GRA on less complex ... and project teams as needed + Collaborates effectively with Regulatory Operations Leader (ROL) + Maintains professional...along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of in… more
- Sumitomo Pharma (Hartford, CT)
- …authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Assesses and communicates ... Team meetings and project teams as needed + Collaborates effectively with regulatory operations leader (ROL) + Maintains professional working relationship with… more
- Pfizer (Groton, CT)
- …to develop effective collaborations with relevant stakeholders (including Study Statisticians, Clinical , Development Operations , PharmSci, Regulatory and ... issues to the Statistics Leadership Team, and Pfizer management in Discovery, Clinical Development, Medical Affairs, Regulatory and other pertinent groups. +… more
- Pfizer (Groton, CT)
- …to develop effective collaborations with relevant stakeholders including Study Statisticians, Clinical , Development Operations , PharmSci, Regulatory and ... issues to the Statistics Leadership Team, and Pfizer management in Discovery, Clinical Development, Medical Affairs, Regulatory and other pertinent groups. +… more
- Hartford HealthCare (Hartford, CT)
- …system. Key Accountabilities: * Provide advice and guidance to market and clinical business units on regulatory , compliance, and industry developments, including ... a behavioral health network, a multispecialty physician group, a clinical care organization, a regional home care system, an...research tools, as well as technology used in operations , such as contract and document management * Strong… more
- Pfizer (Groton, CT)
- …investigators/medical professionals. + Has solid understanding of related disciplines, eg, clinical operations , safety, biostatistics, regulatory , study ... and disease area(s) of assignment. + Partners with other clinical and medical colleagues, clinical operations...degree (PhD, PharmD, or equivalent) and minimum of 2-year Clinical Research experience in industry/CRO, OR BA/BS… more
- Takeda Pharmaceuticals (Hartford, CT)
- …preferred. + 6 or more years' experience in the pharmaceutical industry or clinical research organization, including clinical data management/ clinical ... skills. + Knowledge of FDA and ICH-GCP guidelines for conducting clinical research . + Global/international experience preferred, including the ability… more
- Pfizer (Groton, CT)
- …tools (Outlook, Word, Excel, etc.) + Understanding of drug development process and data operations required for the reporting of clinical trial data (eg data ... purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling...discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and… more
- Hartford HealthCare (Farmington, CT)
- …with Subject Matter Experts. They are familiar with policies, procedures and constraints of clinical operations and the potential impact on the clinical ... and other common practices across the system *_Department Description:_* ITS Clinical Care Systems focuses on the implementation, optimization and support of… more
- Hartford HealthCare (Farmington, CT)
- …with Subject Matter Experts. They are familiar with policies, procedures and constraints of clinical operations and the potential impact on the clinical ... Epic electronic health record across the organization. This team implements the clinical medical record in outpatient areas. Preference will be given to individuals… more
- The Cigna Group (Bloomfield, CT)
- …on data needs specific to organizational priorities and business units (ie Operations , Growth Segments, Regulatory /Compliance, etc.). + Oversee the collection, ... data, research data, and alternative data. + Collaborate with Operations and Technology leads to identify opportunities (through artificial intelligence and… more
- Veterans Affairs, Veterans Health Administration (West Haven, CT)
- …services for all approved research studies involving drugs. They provide clinical , operational, and regulatory expertise and guidance related to drugs used ... and collaborates with investigators, research staff, sponsors, monitors, affiliates, regulatory agencies, clinical providers, and members of the Research… more
- Pfizer (Groton, CT)
- **Role Summary** Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as ... in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities… more
- HealthEdge Software Inc (Hartford, CT)
- …charter to deliverexceptionalvalue for their stakeholders. As aSenior Manager, Product Operations , you will implement andoptimizesystems and processes to support the ... enables our customers to react swiftly to the latest regulatory shifts and competitive pressures. It opens the door...fuel a digital transformation, reduce costs, and improve both clinical outcomes and the member experience. **Your Impact:** +… more
- Pfizer (Groton, CT)
- …data, and business experience providing an understanding of the processes associated with clinical , regulatory , and marketing operations . + Capability to ... effective collaborations internally and externally including, but not limited to, clinical teams, partner lines, regulatory , payer, industry, professional and… more
- Sumitomo Pharma (Hartford, CT)
- …dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible ... Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials. Authors and/or reviews regulatory IND, IMPD,… more