- IQVIA (Durham, NC)
- …Operating Procedures (SOPs), International Council for Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management ... line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to...is to work together with operations, global or regional Quality Management team(s), functional teams, customer and other stakeholders… more
- IQVIA (Durham, NC)
- **Job Level:** Senior/Principal Pharmacometrician, FSP **Location:** Home-based in the US or Canada **Why DSSS?** Data Sciences Staffing Solutions, DSSS or DS3, is a ... our sponsors with fully dedicated resources through a Functional Service Provider ( FSP ) partnership. This affords all the benefits of working for an industry… more
- Parexel (Raleigh, NC)
- …+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for... trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws,… more
- Parexel (Raleigh, NC)
- … Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining ... audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures...Science Liaisons (MSLs) as directed by LSAD or line manager . **Compliance with Sponsor Standards** + Ensures compliance with… more
- Parexel (Raleigh, NC)
- … Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining ... audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures...Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. +… more
- IQVIA (Durham, NC)
- …to clinical studies based on their experience and training. * Manage the quality of assigned staff's clinical work through regular review and evaluation of ... Job Overview Manage a team of clinical staff working in support of clinical...work product. * Identifies quality risks and issues and create appropriate corrective action… more
- Parexel (Raleigh, NC)
- …analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. ** Quality Control** + Ensure that all work is ... will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client...complete and of high quality prior to team distribution or shipment to client.… more
- Parexel (Raleigh, NC)
- …Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead ... providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to… more
- IQVIA (Durham, NC)
- …multiple Clinical Data Management (CDM) Leads across our FSP (Functional Service Provider) and Traditional (Sponsor-Agnostic) delivery models.** **Apply now ... Leads to oversee end-to-end data management delivery for global clinical trials. You'll ensure quality , accuracy, and...+ Your previous roles/job titles may include _Clinical Data Manager , Senior Clinical Data Manager ,… more