- Catalyst Clinical Research LLC (Raleigh, NC)
- As the Clinical Trial Lead you are responsible for oversight of the team of field Clinical Research Associates (CRA) or In-House CRAs who provide ... qualification, selection, monitoring, and close out of sites performing clinical trial (s). Lead Clinical Research Associates/ Clinical Trial … more
- Allucent (Cary, NC)
- …Specialist)/TMF Lead to ensure inspection readiness of the TMF. + Assist CRAs / Clinical Trial Lead with query resolution and aged action item metrics ... need across the globe. We are looking for a Clinical Trial Associate (CTA) to join our...end of the study. + Communicates with the TMF Lead / Project Specialist to follow-up on country and… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …ensure appropriate audit scopes and clinical trial delivery participation. + Lead clinical trial functional areas and study teams on issues related ... tools + Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related… more
- Edwards Lifesciences (Raleigh, NC)
- … studies. **How you will make an impact:** + Act as core team member/ lead biostatistician of assigned clinical trial (s) in US and international/global ... exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience +… more
- IQVIA (Durham, NC)
- …Overview** Clinical Leads/Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to ... by bringing new drugs to the market faster. The Clinical Lead /Senior Clinical Lead...Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
- IQVIA (Durham, NC)
- …are the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst for project ... The Associate Clinical Project Manager/Local Trial Manager is...project leader planning/implementingappropriate corrective and preventative action plans. + Lead the efforts of a project sub-team, responsible for… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …Expert knowledge and adherence to company SOPs. Expert knowledge of the clinical trial development process, including key interface areas with investigators, ... preclinical, and clinical teams. Familiar with general clinical trial designs (superiority, non-inferiority, cross-over, enrichment design. Expert knowledge… 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 ... study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC...assigned by CTM (eg trip report review, newsletter creation, lead CRA team calls etc). + Facilitates effective communication… more
- Actalent (Durham, NC)
- …ability to develop and deliver formal communications. Skills: Project management, Clinical trial , Clinical research, Smartsheets, Vendor management, ... Clinical project management, Medical Device, Clinical operation, Clinical study, Clinical trial management Top Skills Details: Project management,… more
- Allucent (Cary, NC)
- …business processes, and implement technology solutions that align with the organization's clinical trial management goals. The IT Product Manager will have ... adoption. + Oversee data integrity, validation processes, and reporting needs to support clinical trial activities and business decision-making. + Ensure all … more
- United Therapeutics (Research Triangle Park, 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
- System One (Raleigh, NC)
- …be a US Board Certified MD, licensed to practice medicine in North Carolina. No prior clinical trial experienced need, however it is a plus. JOB DESCRIPTION As a ... be responsible for assessing and following the safety of clinical trial participants and collaborate with the...closely with colleagues in other functions including, Regulatory Affairs, Clinical Operations and Patient Engagement + Lead … more
- IQVIA (Durham, NC)
- …Functionally responsible for all team members throughout the duration of each clinical trial . Assures clear client communication, process documentation, and ... documenting that to the direct line manager or divisional lead * Responsible for maintaining client relationships for all...health-related field with at least five (5) years direct clinical trial experience in a CRO or… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …skills in negotiation and consensus decision making. + Expert knowledge of clinical trial and Pharmacovigilance methodologies including detailed comprehension of ... Join Takeda as an Associate Director, Global Patient Safety Clinical Operations in Cambridge, MA, where you will provide... Development Program issues/risks in a proactive matter and lead discussions to mitigate them + Perform tasks of… more
- IQVIA (Durham, NC)
- …scientific, and operational knowledge to harness the vast IQVIA data and clinical trial resources to develop innovative, data-driven, and patient-centered ... and advance this dynamic and rapidly expanding area of clinical development. The Cardiovascular Medical Strategy Lead ...of clinical development. The Cardiovascular Medical Strategy Lead is a subject matter expert with experience in… more
- IQVIA (Raleigh, NC)
- …to the responsibilities listed above, the Therapeutic Strategy VP will be expected to: + Lead and support clinical trial design and all associated aspects ... including drugs, biologics, and devices. This role will focus on clinical -commercial convergence and will encompass all phases of development from discovery… more
- IQVIA (Durham, NC)
- …product offerings, status and trends in assigned TA(s), innovations and advances in clinical trial methodology, and business intelligence. + Broad protocol and ... and data science experts to determine the optimal solution, project design and lead a cross-functional team in proposal development through to award + Assigned to… more
- IQVIA (Cary, NC)
- …laboratory division, Q2 Lab Solutions. Q2 Solutions is a leading global clinical trial laboratory services organization providing comprehensive testing, project ... management, supply chain, biorepository and specimen management, and clinical trial sample and consent tracking solutions. **Essential Functions** + Plan,… more
- Randstad US (Research Triangle Park, NC)
- …in transplant, nephrology and/or immuno-inflammatory indications + Strong knowledge of clinical trial design and execution, including experience with adaptive ... on immunological complications of transplantation. Reporting directly to the Clinical Development Lead the MD and as...study monitoring, data review, and analysis + Collaborate with Clinical Operations in trial setup, conduct, recruitment… more
- Merck (Raleigh, NC)
- …Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc.) for quantitative analyses, within ... drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. +...planning. + Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work… more