- Parexel (Raleigh, NC)
- …work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected ... Works with Precision Medicine Strategy Lead as well as clinical study...Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing Operational Support 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
- Parexel (Raleigh, NC)
- … clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. **Key Accountabilities** **:** **Study Team Support** + ... (lab manual, sample collection procedures and presentation slides) + Manages acquisition of clinical trial samples + Provides support for sample related matters… more
- Parexel (Raleigh, NC)
- …7+ years experience in pharmaceutical/biotech clinical data management / Biometrics ( clinical trial data and/or Real World Data) + Medical affairs experience ... **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote...teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with… more
- Parexel (Raleigh, NC)
- …in Lupus is preferred -Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience The ability ... experience treating rheumatology patients clinically and/or who possess extensive rheumatology clinical trial related experience will be considered for this… more
- Parexel (Raleigh, NC)
- …Contract Leader is responsible for overseeing the site contracting process for clinical trials. The Site Contract Lead will manage the site contracting ... necessary support to cross-functional teams including Start up, Global Clinical Operations, Investigator Payments, Business Development and Feasibility + Provide… more
- WCG Clinical (Cary, NC)
- …frameworks including AI/ML, to integrate and present meaningful analytical insights into clinical trial business needs and customer uses. Our tools analyze ... data to identify insights, forecast trends, and recommend actionable items to improve clinical trial business and operations. In addition to delivery, the D&A… 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
- 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
- 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
- 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
- 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
- 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