- Parexel (Durham, NC)
- …logistics. - Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial biosamples and data monitoring. - Oversee and manage ... **PXL is seeking a clinical operations lead with expertise in ...clinical trial biosamples and data monitoring and completeness from collection through… more
- Parexel (Durham, NC)
- …role.** We're currently seeking a highly experienced Clinical Regulatory Leader , Health Authority Medical Review Team Lead , Master/Senior Medical Review ... more effective therapies to patients worldwide. You will: - Lead strategic regulatory initiatives across diverse product types and...looking to draw upon their wealth of experience in clinical trial design and drug development to… more
- WCG Clinical (Cary, NC)
- …5 years in the following: 1) SAS programming and auditing experience in a clinical trial setting and with regulatory conventions, including CDISC; 2) Carrying ... Clinical , Inc. TITLE: Principal Statistical Programmer - WCG Clinical , Inc. DUTIES: Conduct and lead biostatistical...- WCG Clinical , Inc. DUTIES: Conduct and lead biostatistical analysis projects to analyze and interpret statistical… more
- IQVIA (Durham, NC)
- …(SOPs), policies and practices. Clinical Trial Leader ensure clinical delivery to customers, lead clinical teams and partner with Project ... by bringing new drugs to the market faster. The Clinical Trial Leader is a...into this role. + May work as a primary Clinical Lead alongside other Clinical … more
- IQVIA (Durham, NC)
- …Delivery Manager (TDM) to lead and coordinate global and regional clinical trial management activities. This role ensures the successful planning, execution, ... and closure of clinical trials, whether internally managed or outsourced. The TDM...timely delivery of trial milestones. **Key Responsibilities:** ** Trial Oversight & Management** + Lead the… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …IVRS set-up, central lab set-up, and other vendor selection processes. + Maintaining clinical trial management system (CTMS) information pertaining to the study ... **Knowledge, Skills, and Abilities:** Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.… more
- UNC Health Care (Chapel Hill, NC)
- …Responsible for leading and overseeing the drafting, negotiation, and execution of clinical trial agreements and other related legal agreements between CRP ... achieve efficient, smooth, and consistent negotiation, execution, and administration of clinical trial agreements. Continuously evaluate, assess, and refine… more
- IQVIA (Durham, NC)
- …This Clinical Project Manager/Feasibility role plays a critical role in clinical trial planning and delivery by leading feasibility activities across the ... + **Advanced Responsibilities:** + Act as a Global Feasibility Lead within a therapeutic area, managing a book of...or similar + 3+ years as part of a clinical trial feasibility team at a pharma… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …overseeing project timelines and budgets, and contributing to strategic planning for clinical trial execution. The role will work closely with investigators, ... motivated and organized individual with a strong background in clinical research operations to provide high-level direction of new...+ 1 or more years as research site operations lead + Research Certification in SOCRA , ACRP ,… more
- IQVIA (Durham, NC)
- …on adequate scope of work, clinical trial protocol and other clinical trial information.Participate in and/or lead the budget escalation review ... the development and analysis of fair market value pricing for clinical trial agreements including benchmarking fees and drafting and finalizing financial… more
- IQVIA (Durham, NC)
- …for a Therapeutic Strategy Lead who is experienced in Respiratory global clinical trial development and can support customer engagement and responses to ... To be successful in this role, it is important to understand Respiratory disease clinical trial operations from Phase 1 to Phase 3 and apply operational… more
- IQVIA (Durham, NC)
- **Job Overview** Project Management Analysts (PMA) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives ... faster. The PMA works in partnership with the Project Leader (PL)/ Clinical Project Manager (CPM) providing support...Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying… more
- United Therapeutics (Research Triangle Park, NC)
- …You Are You are a detail-oriented person who has a strong understanding of clinical trial and registry design. You are able to effectively communicate complex ... into abstracts, posters and manuscripts. + Act as the lead project statistician for assigned phase 3b/4 clinical...and medical strategy personnel to align on phase 3b/4 clinical trial objectives, streamline processes, and ensure… more
- IQVIA (Durham, NC)
- …legal, financial and/or technical writing skills. + Strong understanding of regulated clinical trial environment and knowledge of drug development process. + ... taking calculated risks when making decisions. + Ability to lead , motivate, coach and mentor. + Good organizational and...Microsoft Office and e-mail applications. + Good understanding of clinical trial contract management. + Ability to… more
- IQVIA (Durham, NC)
- …components and theory. + Excellent application development skills. + Strong understanding of clinical trial data and extremely hands on in data manipulations, ... ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes. + Minimum of 7+ years of...Knowledge, Skills and Abilities:** + Experience as technical team lead directly engaging clients and coordinating tasks within a… more
- IQVIA (Durham, NC)
- …innovative study designs, such as synthetic control arms, external comparators, and hybrid RWD- clinical trial approaches, to support clinical development and ... and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies… more
- IQVIA (Durham, NC)
- …RWE databases, including large administrative claims data, EMR, disease registries, and clinical trial data. + Demonstrated ability in evaluation and development ... project teams to establish project goals and timelines. + Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies. + Serves… more
- ThermoFisher Scientific (Morrisville, NC)
- …conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites. We prepare detailed audit reports ... for a highly skilled pharma-GMP auditor and risk management leader . This leader will have a significant...and Microbiological) + IT / Computer systems validation + Clinical and commercial stage products and services + Viral… more
- Lilly (Research Triangle Park, NC)
- …safety, quality, service and financial performance at a manufacturing site or clinical trial organization and improve operational planning and execution skills. ... life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover… more
- IQVIA (Durham, NC)
- IQVIA is seeking Study Start-Up Clinical Research Associates to join our Sponsor Dedicated teams. Ideal candidates will have experience in Study Start-Up and at ... in close collaboration with the SSO Study Start-Up Team Lead , the SSO Study Start-Up Manager, and the SSO...a specific study Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC… more
