- ThermoFisher Scientific (Wilmington, NC)
- …We are seeking a ** Project Manager/ Lead or a Sr. CTM** in our FSP, Project Management **Team** . + This role is for the **North America region** and is ... especially as it applies to clinical trials, clinical development and project management . + Ability to coach, mentor and lead global and/or cross-functional… more
- IQVIA (Durham, NC)
- At least 2 years of Clinical Trial Management experience Sickle Cell Disease experience is a requirement Candidates should also have experience in other ... bringing new drugs to the market faster. The Clinical Lead is a member of the core project...training and experience. Req * Requires basic knowledge of Project management practices and terminology. Req *… more
- IQVIA (Durham, NC)
- …combination of education, training and experience. + Requires consolidated knowledge of Project management practices and terminology. + Requires good knowledge ... Leads/Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to...the market faster. The Clinical Lead /Senior Clinical Lead is a member of the core project… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …technology-related fields. + 6 or more years drug development experience. + Project management skills and experience managing implementation of integrations or ... to shine? Join us as a Senior Manager, Clinical Trial Tools & Technologies based remotely reporting to the...delivery life cycle, including deployment strategies, user training and management . + Be primary business change agent to ensure… more
- ThermoFisher Scientific (Greenville, NC)
- …responsibilities; eg process improvements, lead complex programs, have wider management or project coordination responsibilities. + Develops clinical tools ... solutions and deliver results; coordinating the activities of Clinical Management members which are allocated to a project...complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM… more
- IQVIA (Durham, NC)
- …development. Key collaborators are the Project Lead for partnering in overall project management , Clinical Lead for site management , the ... The Associate Clinical Project Manager/Local Trial Manager is a...project delivery by applying a robust set of project management processes designed to enable productivity… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …educator ( CDE ) certification required. The research study comprises a significant project management component; we will thus consider relevant professional and ... Chapel Hill seeks candidates for the position of Research Project Manager and Lead Interventionist. The ...nutrition insecurity. This is a single-center 1:1 randomized controlled trial of 12 weeks total duration designed to test… more
- United Therapeutics (Raleigh, NC)
- …up to 20%. Trial Duties/Key Responsibilities + Serve as the functional lead and point of contact (POC) for all central and field Clinical Monitoring activities ... applicable regulations and industry guidance throughout the duration of the trial . Establish study-specific documentation, inclusive of the Clinical Monitoring Plan… more
- IQVIA (Fayetteville, NC)
- … * Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware * In ... with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate.… more
- Catalyst Clinical Research LLC (NC)
- …+ Coordinate, plan and execute Investigator Meetings as needed. May need support from a Senior Project Manager. + Lead internal project team meetings. + May ... lead sponsor project team meetings or collaborate with a Senior ... project matters in a timely manner to appropriate team members, senior management , and sponsor. Powered by… more
- IQVIA (Durham, NC)
- … project or program progress, trends, and milestones indicate intervention required. Lead and support development of a project delivery strategy and budget ... as a therapeutic and/or operational expert throughout the new business and program/ project delivery lifecycle for the Real World Solutions group in IQVIA.… more
- System One (Durham, NC)
- …handling large datasets. Familiarity with Sage Intacct, QuickBooks, and CRIO (Clinical Trial Management System) is preferred, as well as experience working ... Title: Accounts Receivable Lead Location: Durham, NC - Hybrid Type: Direct...for invoice determination + Create invoices per the Clinical Trial Agreement, send invoices correctly, and resolve billing discrepancies… more
- United Therapeutics (Raleigh, NC)
- …reports and follow-up letters for each monitoring visit using either a clinical trial management system (CTMS) or study-specific process + Support Study Product ... close-out. Work with monitoring team members and cross functional project team members to ensure efficient and effective conduct...may collaborate with the In-house CRA (iCRA), Monitoring Team Lead (MTL), Management or other study team… more
- IQVIA (Durham, NC)
- …scientific, operational and data science experts to determine the optimal solution, project design and lead a cross-functional team in proposal development ... Will serve as a Therapeutic and Operational SME throughout the program/ project delivery lifecycle to increase IQVIAs therapeutic market share. This pivotal… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …identification and development of applicable processes and tools + Establish and lead proactive risk-based compliance assessments for clinical trial delivery ... leadership on key performance indicators and mitigation strategies for clinical trial delivery **_A_** **_CCOUNTABILITIES:_** Compliance Management + Oversee and… 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). These ... Radiation Safety Subcommittee. SOCRA , RAC , or ACRP certification preferred Project management experience Essential Skills: Demonstrated experience in clinical… more
- Verista (NC)
- …and continuous improvement of Laboratory Operations, Clinical, Biostatistics and Data Management , Bioprocess R&D and Regulatory/Risk Management applications and ... Director, R&D Systems. These systems include SAS Office Analytics, Electronic Trial Master File (eTMF), AWS high performance compute/storage, Electronic Lab Notebook… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …decisions while focusing on multiple priorities. Advanced leadership, issue resolution and project management skills. Expert ability to ensure timely initiation ... with marketed product and or new submission dossiers. May lead and contributes (and or reviews) to update core...on a periodic basis. + Support Clinical Operations throughout trial execution, providing an additional layer of quality and… more
- Cardinal Health (Raleigh, NC)
- …+ **Cross-functional Collaboration** + Work closely with clinical operations, project management , medical affairs, legal, medical writing, nonclinical, ... and ensure timely submission of regulatory, and clinical documents to meet project timelines and milestones. + Maintain regulatory filings and documentation in… more
- Edwards Lifesciences (Raleigh, NC)
- …as SAS and/or R required + Strict attention to detail + Proven successful project management leadership skills + Proven expertise in both Microsoft Office Suite ... will make an impact:** + Act as core team member/ lead biostatistician of assigned clinical trial (s) in...often leads a cooperative effort among members of a project team + Ability to interact professionally with all… more