- ThermoFisher Scientific (Greenville, NC)
- …be crucial in determining and successfully implementing advanced quality assurance processes. **Role:** GCP Process Lead , FSP Dedicated **Location:** ... **Environmental Conditions** Office **Job Description** **Job Summary** As the GCP Compliance and Process Lead at Thermo Fisher Scientific, you will… more
- ThermoFisher Scientific (Chicago, IL)
- …and coordinates all aspects of the clinical monitoring and site management process . Conducts remote or on-site visits to assess protocol and regulatory compliance ... procedures and guidelines from different sponsors and/or monitoring environments (ie FSO, FSP , Government, etc.). Acts as a site processes specialist, ensuring that… more
- ThermoFisher Scientific (Greenville, NC)
- …adhere to ethical standards, regulatory requirements and Good clinical Practice ( GCP ) guidelines. + **Continuous Improvement:** Implement process improvements ... Operations at the client. The Patient Recruitment & Retention Strategy Lead encompasses strategic leadership and oversight of patient recruitment efforts across… more
- Parexel (Austin, TX)
- …study execution in accordance with applicable prevailing laws, Good Clinical Practices ( GCP ), and sponsor standards. The Sr. CRA is accountable for site management ... sites (eg patient safety, site quality and compliance with GCP ), to maintain investigator and site staff engagement and...and development processes and ability to gain command of process details + Demonstrated knowledge of global and local… more
- ThermoFisher Scientific (Wilmington, NC)
- …Conditions** Office **Job Description** **CSM (Clinical Study Manager):** **OBJECTIVES:** ** Lead or support study operational strategy and planning and oversee ... Development Plan.** **In close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable):** **Support… more
- ThermoFisher Scientific (Greenville, NC)
- …on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Essential Functions** + Manages all clinical ... aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP . In accordance to project specific requirements, may assume Lead CTM… more
- ThermoFisher Scientific (Wilmington, NC)
- …on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all ... aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP . In accordance to project specific requirements, may assume Lead CTM… more
- ThermoFisher Scientific (West Hills, CA)
- …accordance with the approved monitoring plan. Participates in the investigator payment process . Ensures a shared responsibility with other project team members on ... procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and… more
- Parexel (Austin, TX)
- …Experience** : + Demonstrated understanding of clinical research, the drug development process , and industry guidelines and regulations, eg, ICH- GCP . + Extensive ... content review. **Document Project Management** + Act in the capacity of project manager/ lead for medical writing projects, which may entail serving as the primary… more
- IQVIA (Durham, NC)
- **Job Overview:** As a Lead Medical Writer on most types of writing projects. You will prepare assigned documents in accordance with IQVIA Standard Operating ... medical and/or technical writing/regulatory knowledge, including Good Clinical Practice ( GCP ), along with developments and advances in drug development/medical… more
- IQVIA (San Diego, CA)
- …Hiring multiple Clinical Data Management (CDM) Leads across our FSP (Functional Service Provider) and Traditional (Sponsor-Agnostic) delivery models.** **Apply ... now and have your resume considered for Lead Data Manager opportunities across multiple teams - allowing...data management staff and promote best practices. + Drive process improvements and ensure regulatory and SOP compliance. **Who… more
- Kelly Services (Irvine, CA)
- …with key internal and external stakeholders. + **Shape** - Participate in departmental process improvement activities. + ** Lead ** - Take ownership in critical ... Kelly Science and Clinical FSP is currently seeking a Associate Clinical Research...trial within the allocated countries, in accordance with the ICH- GCP , applicable legislation and Company Standard Operating Procedures +… more
- ThermoFisher Scientific (Suwanee, GA)
- …and coordinates all aspects of the clinical monitoring and site management process . Conducts remote or on-site visits to assess protocol and regulatory compliance ... procedures and guidelines from different sponsors and/or monitoring environments (ie FSO, FSP , Government, etc.). Acts as a site processes specialist, ensuring that… more
- ThermoFisher Scientific (Suwanee, GA)
- …Specific Information** Join Thermo Fisher Scientific as a Medical Director/Clinical Trial Physician( FSP ) based in the United States and be part of a world-class ... of issues in consultation with the Global Medical Indication Lead + Interpret the clinical trial data for regulatory...aspects by understanding and applying all relevant SOPs and GCP + Closely collaborate with the cross functional study… more