- Actalent (Durham, NC)
- Description: Position Overview The Clinical Affairs Project Manager (PM) II is responsible for creating and maintaining clinical study timelines, ... Vendor management, Clinical project management, Medical Device, Clinical operation, Clinical study , Clinical trial management Top Skills Details:… more
- IQVIA (Durham, NC)
- …DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation of clinical studies including: * Manages projects of full scope regional ... for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and...projects are done within scope * Reviewing and identifying project study trends and proactively responding to… more
- IQVIA (Durham, NC)
- …that advance healthcare and patient treatment options around the world. As Senior Project Leader/ Clinical Program Manager you will liaise directly between ... enabled by best-in-class technology and data analytics.This role owns study and or program level timelines and planning; Microsoft...the Clinical Lead for site management, the Project Vendor Manager , the Project … more
- IQVIA (Durham, NC)
- The Associate Clinical Project Manager /Local Trial ...of the core project team responsible for project delivery of clinical studies to ... the Project Lead for partnering in overall project management, Clinical Lead for site management,...necessary. + When assigned as project vendor manager + Develop the study level vendor… more
- North Carolina State University (Raleigh, NC)
- …in research studies + Must have strong project management/ project coordinator experience as it relates to clinical research Preferred Qualifications: ... for the planning, organization, conduct, and evaluation of multi-faceted clinical research protocols, including study execution, developing strategies… more
- ThermoFisher Scientific (Morrisville, NC)
- …CRO Management. In this role, the primary responsibilities include: + Participate as a clinical study representative for project core teams. + Participate in ... History File (DHF) project . + Interact as the primary clinical studies representative to Pharmaceutical partners concerning IVD study requirements. +… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- …Conference of Harmonization- Good Clinical Practice (ICH-GCP). You work closely with study Project Management to ensure clinical delivery and execution ... performance concerns, evaluate cause and mitigate risk to the study . Escalate CRA performance issues to Clinical ...progress of study for client or internal Project Manager as appropriate. + Assists with… more
- IQVIA (Durham, NC)
- We are seeking a ** Project Manager ** to join IQVIA Laboratories in **Durham, NC** . We hire passionate innovators who drive healthcare forward through thoughtful ... we transform and accelerate research and development. As a Project Manager , you will be managing all...development process including bid defense meetings. + Monitoring the Project Management Plan, timelines, deliverables, and manage study… more
- United Therapeutics (Research Triangle Park, NC)
- … methodology, protocol design, project management and regulatory requirements for clinical studies to be reviewed by health authorities + Knowledge of ... management, and execution of Phase I through Phase IV clinical studies and support the conduct of...for sites and/or Contract Research Organizations (CRO); Lead final clinical study report writing to summarize the… more
- Allucent (Cary, NC)
- …therapies to patients in need across the globe. We are looking for an IT Product Manager - Clinical to join our A-team (hybrid*/remote). As an IT Product ... Manager - Clinical at Allucent, you are...third-party vendors to facilitate communication and ensure alignment of project objectives. + Identify opportunities for optimizing business processes… more
- American Heart Association (Durham, NC)
- …does your career. The American Heart Association has an excellent opportunity for a ** Clinical Data Manager ** in our **National Center** office. Location of the ... clinical datasets (including real world data) from multiple American Heart Association clinical trials, research studies and registries as well as other large… more
- ThermoFisher Scientific (Raleigh, NC)
- …Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed ... clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies . This position requires overnight travel either regionally… more
- Teleflex (Morrisville, NC)
- …ethical manner + Strong understanding of principles used to find, analyze and assess clinical studies and appropriately apply them in the application of Teleflex ... Clinical Affairs Manager Coronary (Remote) **Date:**...Specialists, and Teleflex team members. + Participate as a clinical expert on project teams, committees and… more
- IQVIA (Durham, NC)
- …and figures, and clinical study reports for Phase I-IV clinical pharmacology studies , such as dose tolerance, dose proportionality, mass balance, concept ... population PK/PD studies . + Consult with clients Clinical Pharmacology staff on study design, or...on project -related cross functional teams that include Project Manager , CRA, Data Manager ,… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …**GOALS:** + Conduct data-driven feasibility assessments for Phase I - IV clinical studies , including protocol design optimization, country/site feasibility and ... define an optimal geographic country footprint and proposed sites for participation in a clinical study . + Leverage leading industry tools and data sources to… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …production (Pediatric Study Plans, Protocols, Diversity Plans, Briefing booklets, clinical study reports, integrated submission dossiers and other regulatory ... the identification, formulation and implementation of protocol amendments and review of Clinical Study Reports in collaboration with leading physician. +… 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 ... staff through co-monitoring and training visits. + **Collaboration:** Work closely with study team members to support project execution. + **Travel** : 6-10… more
- IQVIA (Durham, NC)
- …company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts ... all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the… more
- Edwards Lifesciences (Raleigh, NC)
- …, Biostatistics, TMTT** , you will use your expertise as biostatistical lead in clinical study design projects for pivotal trials, while overseeing activities to ... ensure proper design, analysis, and presentation of clinical studies . **How you will make an...with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial… more
- IQVIA (Durham, NC)
- …to request for proposals (RFP). May be expected to present at bid defenses. + Clinical Study Report (CSR): Reviews or drafts CSR or statistical report. + ... + Leadership: Perform statistical team lead role on single studies . Through this, works closely with the Project...risks. Where possible, anticipate risks to minimize need for study level escalations. + Other Clinical Data… more