- Catalyst Clinical Research LLC (Raleigh, NC)
- …Project Manager. + Internal support is provided to the Field Monitor from the assigned Clinical Trial Associate . + Works closely with the extended study team ... As a Senior Clinical Research Associate , you will monitor clinical trial programs and manage regional clinical trial sites to support biological… more
- Edwards Lifesciences (Raleigh, NC)
- …the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience + The ... + Act as core team member/lead biostatistician of assigned clinical trial (s) in US and international/global ...trials with skill levels exceeding the requirements of the Associate Manager Required or + Master's Degree or equivalent… more
- J&J Family of Companies (Raleigh, NC)
- …of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation ... Sr Clinical Research Associate - 2406209639W **Description**...parameters of study hypothesis, as well as to monitor clinical trial /study safety, in keeping with protocols,… more
- ThermoFisher Scientific (Raleigh, NC)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... required. Ensures study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC check of reports generated from… more
- IQVIA (Raleigh, NC)
- Job Overview Associate Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing ... new drugs to the market faster. The Associate Project Lead is a member of the core...Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
- IQVIA (Durham, NC)
- …au niveau mondial Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex ... Clinical Trials Regulatory Management department. **RESPONSIBILITIES** + Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial … more
- United Therapeutics (Durham, NC)
- …reports); Oversee database generation and production of tables and listings; Ensure clinical trial material (CTM) is available for sites and/or Contract ... + Demonstrated understanding of the overall drug development process with clinical trial design, study implementation, sponsor/site interactions, scientific and… more
- IQVIA (Durham, NC)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... IQVIA MedTech is seeking a Clinical Research Associate II with Medical...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- AbbVie (Durham, NC)
- …Responsible for conducting and delivering fit for purpose analysis related to clinical trial feasibility including, study design, study benchmarking, country and ... demonstrated high-level analytics and leadership competencies + Advanced domain knowledge in clinical trial feasibility and real-world data sources + Experience… more
- IQVIA (Durham, NC)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. *… more
- IQVIA (Durham, NC)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive,...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- IQVIA (Durham, NC)
- **Role Overview:** As a Clinical Research Associate , you'll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be ... initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.… more
- IQVIA (Durham, NC)
- IQVIA is seeking a Senior Clinical Research Associate with at least 2 years of monitoring experience in one of the following therapeutic areas: Central Nervous ... with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines +… more
- IQVIA (Durham, NC)
- **Job Overview** Join our team as a Clinical Research Site Manager, where you'll play a crucial role in ensuring our study sites operate seamlessly and adhere to all ... selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. +… more
- Astrix Technology (Raleigh, NC)
- …space. + Working knowledge of Clinical & Regulatory systems such as Clinical Trial Management System (CTMS), electronic Trial Master Files (eTMF), ... for the sale and growth of Astrix Technology Group's Clinical and Regulatory Consulting services to a portfolio of...representative of those that must be met by an associate to successfully perform the essential functions of this… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …**How you will** **contribute:** + Oversee and direct the work of the Clinical trial disclosure programming team (within the Programming Center of Excellence) ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Programming in Cambridge, MA, where you will...Standard code, AI and ML applications). + Collaborate with Clinical Trial Transparency Teams to implement data… more
- UNC Health Care (Chapel Hill, NC)
- …modifications; and overseeing budget development. This position will also negotiate clinical trial budgets. Post-award activities include detailed reconciliation ... serve. **Summary:** The Department of Pediatrics is seeking an experienced clinical Research Administrator for the Department's centralized administrative core. The… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …binder, including entering regulatory and study information in the electronic clinical trial management system (OnCore) and eRegulatory binder (Florence). ... Dependent on Qualifications/Experience Position Summary/Description: The purpose of the Regulatory Associate Lead is to facilitate the conduct of oncology … more
- IQVIA (Durham, NC)
- …treatment, (Oncology (hematology and solid tumor) and / or ImmunologyTherapeutic Area + Clinical trial research experience. + Knowledge of the drug development ... Integrator, CMC Leader, Study Responsible Physician, Study Responsible Scientist, Global Clinical Research Associate , CTL&D Specialist + Other Interfaces:… more
- IQVIA (Durham, NC)
- … development and bring new medicines to patients faster through successful trial delivery. ** Associate Director, Software Engineering - The Role** This ... harnesses our global healthcare insights, working closely with our clinical and therapeutic experts to power evidence-driven design, speed...for managing a team of software engineers. As an Associate Director, you will lead a high performing group… more