- 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 (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
- IQVIA (Durham, NC)
- **Job Overview** With oversight at a team/site/staff level, lead complex studies and submissions. Develop protocols, review case report forms (CRFs), and develop ... Prioritizes and works proactively to gain efficiency. * Leadership: Perform as lead statistician on complex studies and for integrated summaries or eSubmissions,… 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 (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
- IQVIA (Durham, NC)
- …design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate ... log and follows issues to appropriate resolution. * Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project… more
- Parexel (Annapolis, MD)
- …of in-house trials/ process design are beneficial + Excellent knowledge of GCP and regulations **Education:** + Bachelor's Degree or 3 years' clinical research or ... timeline or other concerns to the attention of the Global Study Start-Up Lead and/or Project Team and actively participates in finding solutions. As a member… 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
- Parexel (Helena, MT)
- …solve challenges in complex, multi-faceted projects. + Exhibits strong ability to lead in a matrix environment, communicate effectively at all levels, and present ... clinical trials. + Experience in project management, CRO experience, change management or process design are beneficial + The candidate must have a good working… more
- Boehringer Ingelheim (Ridgefield, CT)
- …high regard for our employees. The Senior Associate Director (SAD) Site Management Lead will support the Executive Director Site Management & Monitoring to oversee ... effectively and efficiently across multiple therapeutic areas in full compliance with GCP /ICH, quality, safety of patients and business goals. The SR AD, Site… 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
- 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
- IQVIA (Dallas, TX)
- Internal Job Description **Location: Homebased anywhere in the US** **Purpose:** Join our FSP team today! In this role you will plan and coordinate the development ... **Required Knowledge, Skills and Abilities:** + Experience as technical team lead directly engaging clients and coordinating tasks within a programming team… more