- Parexel (Raleigh, NC)
- **Job Summary:** Core member of the Clinical Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial (s) to deliver ... + Very strong vendor management skills; outsourcing, contracting, and sourcing of clinical trial services + Results-driven: demonstrated ability of completing… 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
- Norstella (Raleigh, NC)
- …& analytics **Requirements** + Deep knowledge and expertise of the pharma strategic Clinical trial landscape (Clin Dev/Ops, clinical development plan ... Sr. Director/VP/ Clinical Delivery Lead , Advisory Services Company:...+ Experience using data analytics and services to solve clinical trial challenges + Understanding of how,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, ... Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global … 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
- Sumitomo Pharma (Raleigh, NC)
- …assigned asset(s) within the Ophthalmology therapeutic area + Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors ... development plan(s) for assigned asset(s) and serve as the Clinical Research Lead for stem cell program...clinical data output + Contributes to interpretation of clinical trial results and the writing of… more
- Parexel (Raleigh, 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 (Raleigh, 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
- Sumitomo Pharma (Raleigh, NC)
- …all relevant ethical, regulatory, and legal standards. + May participate in or lead clinical development contributions to due diligence or other business ... clinical research program with minimal direction + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing … more
- Gilead Sciences, Inc. (Raleigh, NC)
- …associated capabilities to support the CDS objectives + Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ... ready to make a direct impact. We believe every employee deserves a great leader . People Leaders are the cornerstone to the employee experience at Gilead and Kite.… more
- Parexel (Raleigh, NC)
- … Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient ... at the trial level throughout the preparation, conduct and reporting phase of clinical trial . During the clinical trial , SP is responsible to provide… 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
- Parexel (Raleigh, NC)
- …client in making budget and contractual decisions against the impacts to client clinical trial timelines + Follow client processes to develop, negotiate, track ... oversee the global site budget process + Work with clinical trial sites and directly negotiate cost,...contract templates within the Legal division approved parameters + Lead study level site contracting activities, direct other ICL… 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
- Cordis (Raleigh, NC)
- …support the dissemination of key messages + Present at internal meetings any relevant clinical trial data and facilitate the understanding of trial outcomes ... required 2. Strong knowledge of drug-eluting technologies, vascular biology, and clinical trial methodology. 3. Experience supporting product launches and… 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
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, ... clinical , statistical, and regulatory literature for current clinical trial results, regulatory trends and new...or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team… more