- Allucent (Cary, NC)
- …life-changing therapies to patients in need across the globe. We are looking for a Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a ... other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country,...Sr . CTL) + In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in… more
- IQVIA (Durham, NC)
- … teams to improve patients' lives by bringing new drugs to the market faster. The Senior Clinical Lead is a member of the core project team responsible ... Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical… more
- Actalent (Raleigh, NC)
- …to no guidance. + Serve as mentor/coach for all assigned CRA 1 and Clinical Trial Assistant (CTA) personnel, and provide input for performance evaluations. + ... complex on-site and in-house site assessment for approximately 30-50 clinical sites with minimal to no guidance. Act as...+ Manage and oversee continuing regulatory, contract completion and trial process work by CRA 1 through trial… more
- J&J Family of Companies (Raleigh, NC)
- Senior Clinical Research Associate - 2406171534W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Clinical ... day-to- day aspects of investigational site activities on assigned clinical trials. The Senior Clinical ...for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are… more
- J&J Family of Companies (Raleigh, NC)
- …will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, ... clinical studies in Oncology. Together with the Clinical Leader , the Study Responsible Physician will...presentations post-filing. * May review/co-author medical publications emerging from clinical trial results. * May act as… more
- United Therapeutics (Durham, NC)
- …oversight of sites, vendors, and United Therapeutics staff responsible for conducting clinical trial activities. Compile and report quality metrics, building ... customers and ensuring continuous improvement in the conduct of clinical trial activities. This is a hybrid...in biopharmaceutical research & development or CRO + For Senior Oversight Lead level: + 10+ years… more
- Merck (Raleigh, NC)
- …The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed ... clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head...Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT). + Collectively and… more
- ThermoFisher Scientific (Morrisville, NC)
- …**How will you make an impact?** The ** Sr . Director, Procurement - Clinical Research Group (CRG)** is the global leader responsible for developing and ... will be a key partner to the divisional operations leader with a focus on strategy, execution and implementation....proficiency with core Procurement skills relevant to sourcing outsourced clinical trial services + Strong influencing skills… more
- United Therapeutics (Durham, 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
- IQVIA (Durham, NC)
- …write scientific documents eg Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff May strategically ... Job Description Summary Acts as a Clinical Trial Regulatory Manager (CTRM) on...and welfare and/or other benefits. IQVIA is a world leader in using data, technology, advanced analytics, and expertise… more
- IQVIA (Durham, NC)
- …and clinical study protocol. The Senior Study Leader is the leader of the cross-functional clinical trial team, guides planning and management of ... adjust quickly to changing conditions and business needs. Accountabilities Leader of the Clinical Trial ...team with per needed-basis oversight from the Study Director-community Lead and support from the Clinical Operations… more
- J&J Family of Companies (Raleigh, NC)
- …of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate. ... Senior Site Contract Manager - 2406185356W **Description** Johnson...and contracts. **Key Responsibilities:** + Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds. The EDC Engineer maintains and serves as an ... and empower you to shine? Join us as a Senior Electronic Data Capture (EDC) Engineer. At Takeda, we...Accountabilities** + Create eCRF specifications, design, develop and validate clinical trial setup in EDC + Review… more
- IQVIA (Durham, NC)
- **PURPOSE** IQVIA Design Analytics delivers clinical trial design optimization services that integrates drug development and clinical trial expertise ... for complex Design Analytics opportunities / projects across the clinical trial design lifecycle + Utilizes multiple...influence in all directions. Gains trust and respect of Senior leadership. + Demonstrates capability to apply data and… more
- IQVIA (Durham, NC)
- …regulatory & drug development support services into emerging biopharmaceutical company clinical trial offerings. Interface with clients in collaboration with ... customer goals in oncology. Provides strategic regulatory advice towards efficient clinical development and navigation of US & European regulatory frameworks.… more
- Allucent (Cary, NC)
- …discipline + Experienced in CDISC-compliant dataset creation and formatting as well as clinical trial result visualization and reporting + Minimum 3 years of ... Pharmacology Modeling and Simulation (CPMS) team at Allucent. As a Senior Programmer/Analyst you will lead data programming and visualization activities… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, ... true to the best of my knowledge. **Job Description** Senior Manager, Feasibility Are you looking for a patient-focused,...sponsor or CRO. + 6+ years of experience in Clinical Operations, Data Analytics, global feasibility, and trial… more
- IQVIA (Durham, NC)
- …. Preparation, review, negotiation and management of site regulatory documentation and clinical trial agreements with sites and sponsors . Maintains, reviews, ... with Legal if necessary to ensure contract integrity * Lead preparation and delivery of study documents related to...multiple tasks with conflicting deadlines * Good understanding of Clinical Trial processes including start up, monitoring,… more
- IQVIA (Raleigh, NC)
- …(internal and external with Investigator sites) and reduce data latency within Quintiles clinical trial systems inclusive of IVxS, EDC, CTMS, QRPM, Data Factory, ... in data management. May perform role of customer site lead , responsible for managing and delivering programme of studies...SKILLS AND ABILITIES** + Experience working in Drug Discovery, clinical trial conduct, clinical data… more
- Merck (Raleigh, NC)
- …and ensures continuity of site relationships through all phases of the trial . + Performs clinical study site management/monitoring activities in compliance ... as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and… more