- 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
- 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
- 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
- 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 (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 (Knightdale, 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
- 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
- Merck (Raleigh, NC)
- …and retention efforts to achieve study milestones. + Upon Request from Global Clinical Trial Operations (GCTO) + Recommends study sites and identifies potential ... (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities. **Location:** This… more
- Chiesi (Cary, NC)
- …in a changing environment with a sense of urgency. + Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and ... looking for_** **Purpose** The primary responsibility of this role is to lead the development, execution, and implementation of the global Medical Affairs strategy… more
- ThermoFisher Scientific (Morrisville, NC)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …documents such as Briefing Books (BB), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Investigator's Brochures (IBs), New Drug ... Regulatory Writing and Submission Support, _Oncology and Marketed Products_ . Team lead , based in Cambridge, MA/Virtual. Here, you will be a vital contributor… more
- Sumitomo Pharma (Raleigh, NC)
- …scientific and medical information for key stakeholders. The Vice President will lead the global medical affairs functions for investigational and marketed products. ... of global medical affairs activities for investigational and marketed products. + Lead development of systems and processes to ensure harmonized and integrated… more