- IQVIA (Durham, NC)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Manages regional study budgets + ... functional managers as needed + Leads planning and management of the assigned clinical study (ies) from feasibility through closeout activities for region, in… more
- Eurofins US Network (Winston Salem, NC)
- …study participants based on study eligibility for participation in ongoing clinical studies based on specified inclusion and exclusion criteria. + Serve ... CDMO, advanced material sciences and in the support of clinical studies .** **In over just 30 years,...**Primary Duties and Responsibilities:** + Maintain a database of clinical study participants. + Document all communication… more
- Dentsply Sirona (Charlotte, NC)
- …visualization). + Provide clinical guidance on product design and validation, including study design for reader and standalone studies for AI models. + ... Research Manager AI** Do you want to work with clinical studies in a world leading dental...EU MDR and FDA. + Preparation and submission of clinical study documentation to Independent Ethics Committees/Review… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …study plans reviews + Participate in the review of Regulatory Documents ( Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica ... + **Provide quality oversight on the conduct of the clinical studies ** + Perform periodic quality reviews...** + Initiate the Quality Risk Assessment for every clinical study + **Qualification and periodic assessment… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …Associate Director of Clinical Operations serves as project lead for clinical studies . Oversees the clinical feasibility assessment, strategic planning, ... and operations of clinical trial programs or studies . Executes on these global programs or studies...to submission to regulatory authorities (eg, protocols, investigator brochures, clinical study reports). + Manages clinical… more
- Parexel (Raleigh, NC)
- …for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international ... (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant...escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking ... and reviewed for completeness and accuracy to ensure data integrity. + Reconciles clinical supplies and drug accountability records at study sites. + Identifies… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Summary** Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the ... oversight and management of Otsuka clinical studies , including coordination with other relevant...Contribute to the development and review of all critical clinical study documents, including clinical … more
- Parexel (Raleigh, NC)
- …+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies , including knowledge of company direction, investigational product(s), ... trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical... Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study … more
- ThermoFisher Scientific (Wilmington, NC)
- …scientific information, contribute to site selection, contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), ... in the Life:** + Provide medical leadership to the study teams, including creating clinical trial protocols...clinical trials + Real time Medical Monitoring of clinical studies : ensure medical validity of each… more
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