- 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
- ThermoFisher Scientific (Wilmington, NC)
- … Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical operational and quality aspects of allocated studies, of moderate to ... clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy… more
- ThermoFisher Scientific (Greenville, NC)
- …Clinical Study Manager responsibilities. **Essential Functions** + Manages all clinical operational and quality aspects of allocated studies, of moderate ... with support from line management. Works to ensure that all clinical deliverables meet the customer's time/ quality /cost expectations. Maintains profitability… 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 (Austin, TX)
- …+ 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 (Richmond, VA)
- … 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 (Columbus, OH)
- … 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
- ThermoFisher Scientific (Wilmington, NC)
- …and mentoring to your staff regarding all general aspects of the Clinical Team Manager (CTM) and Clinical Manager roles. You will be responsible for ... to feasibility projects * Ensure the timely execution of clinical deliverables with a focus on quality ...of clinical deliverables with a focus on quality deliverables. In those cases, develop and drive the… more
- ThermoFisher Scientific (Carlsbad, CA)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... + Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study… more
- ThermoFisher Scientific (West Hills, CA)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... + Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study… more
- ThermoFisher Scientific (Wilmington, NC)
- …Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **CSM ( Clinical Study Manager ):** **OBJECTIVES:** **Lead or support study ... Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable):** **Support...or oversee the execution of select study/ies in assigned clinical program(s) in compliance with quality standards… 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
- ThermoFisher Scientific (Wilmington, NC)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs, Clinical , Quality , Pharmacovigilance and Legal teams to ensure… more
- Parexel (Austin, TX)
- …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 (Jefferson City, MO)
- …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 (San Diego, CA)
- …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
- ThermoFisher Scientific (Suwanee, GA)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high- quality ,...trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures… more
- BeOne Medicines (San Mateo, CA)
- …as required with external, global and/or regional stakeholders such as eg, FSP partners, clinical operations leaders in other regions, and monitoring ... ensures that novel ideas on how to deliver on clinical trials are generated and considered ** Quality **...Solid leadership and management experience either as direct line manager or as cross functional team lead + Strong… more
- BeOne Medicines (Emeryville, CA)
- …as required with external, global and/or regional stakeholders such as eg, FSP partners, clinical operations leaders in other regions, and monitoring ... ensures that novel ideas on how to deliver on clinical trials are generated and considered. ** Quality **...Solid leadership and extensive experience either as direct line manager (required for those with line management responsibilities) or… more
- ThermoFisher Scientific (Boston, MA)
- …all Good Manufacturing Practices (GMP) Safety Standards **Job Description** **Sr. Scientist - FSP - Quality Control** Shift: Full-Time; Monday - Friday; 8am-5pm ... clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy… more