- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP / Document Audits supports end-to-end ... of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports...at least 4 or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the… more
- DeepHealth (Somerville, MA)
- A Clinical Study Manager (CSM) is responsible for overseeing the planning, execution, and close of clinical trials to ensure they are successful and conducted in ... clinical studies, ensuring adherence to the protocol and regulatory requirements (eg, GCP , ICH). Issue Resolution: Identifies risks or issues during the trial and… more
- Actalent (Wilmington, NC)
- …logs, including information such as lot number and drug vs. placebo. Document laboratory data and adverse reactions, promptly notifying investigators and sponsors of ... Communicate recruitment status and clinical needs to investigators and Site Manager . Build relationships with monitors from sponsoring companies through various… more
- HCA Healthcare (Nashville, TN)
- **Description** **Introduction** Do you have the career opportunities as a Manager , Data Quality you want with your current employer? We have an exciting opportunity ... expertise! **Job Summary and Qualifications** **Job Summary** The Data Quality (DQ) Manager within the Data Office, is responsible for developing data quality… more
- Ally (Lansing, MI)
- …DSS, FedRAMP) to privileged access environments. * Support internal and external audits , document control procedures, and mitigate audit findings. * Privileged ... IAM, Linux PAM, Kubernetes RBAC). * Proven success managing audits and delivering compliance with regulatory frameworks. * Excellent...CISSP, CISM, or CCSP * Certified Identity and Access Manager (CIAM) * Azure/AWS/ GCP Security or Architect… more
- University of Miami (Miami, FL)
- …Department of Clinical Translational Research Site is currently seeking a full time Manager , Clinical Research Nursing to work in Miami. The Manager , Clinical ... duties, from protocol development and initiation to study close-out. The Manager , Clinical Research Nursing provides leadership and training/mentorship in planning,… more
- University of Rochester (Rochester, NY)
- … audits . - lans and operationalizes strategies to monitor, document , report, and follow-up on unanticipated occurrences, protocol deviations; develops and ... with Standard Operating Procedures and Good Clinical Practices. The Clinical Research Manager (CRM) is responsible for the day to day oversight and management… more
- The Hartford (Columbus, OH)
- …the accuracy, consistency, and reliability of CMDB data through regular audits and validation processes. + Stakeholder Collaboration: Working closely with various ... other CMS capabilities. + Leading customer sessions to gather, define, and document business and technical requirements. + Implementing new ServiceNow features and… more
- University of Pennsylvania (Philadelphia, PA)
- …(PI), study team and Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research nurses (CRNs). The CRC ... Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits , and ongoing training sessions; maintain complete and accurate records… more
- Caris Life Sciences (Phoenix, AZ)
- …accordance with the site and sponsor requirements. + Conduct quality control (QC) audits of the clinical database to identify and correct discrepancies. + Ensure ... compliance with Good Clinical Practice ( GCP ), FDA regulations, Institutional Review Board (IRB) requirements, HIPAA regulations, site standard operating procedures… more
- University of Pennsylvania (Philadelphia, PA)
- …recruiting, consenting and enrolling eligible subjects per protocol using GCP guidelines. Scheduling clinical and research visits, interacting with clinicians ... labs) and transport/shipment of specimen samples, preparing trials for audits and inspections. The CRC will participate in study...to adhere to all University of Pennsylvania, FDA, and GCP guidelines. The CRC-B/C will be responsible for accurate… more
- Capital One (Plano, TX)
- …member of the Audit team, the candidate will focus on audits of critical technology functions including cloud-based technology implementations, application controls, ... and cybersecurity risks.** **Responsibilities:** **-Execute major components of audits , including critical technology functions, cloud-based infrastructure, cybersecurity, risk… more
- University of Miami (Miami, FL)
- …Specifics: DUTIES & RESPONSIBILITIES: + Assist Principal Investigator and Sr. Manager with assessing feasibility. + Organizes and participates in Study Initiation ... submitted for appropriate review. + Assists PI in obtaining informed consent and document the informed consent process. Enter required information in Velos. + Ensure… more
- Warner Bros. Discovery (Atlanta, GA)
- …:** **OPERATIONS/PROJECT MANAGEMENT** + Lead the execution of Security & Compliance audits and assessments owned by the team, ensuring timely and high-quality ... with external Qualified Security Assessors (QSAs) during formal PCI DSS audits , manage timely collection of required artifacts, track remediation of identified… more
- United Therapeutics (Research Triangle Park, NC)
- …packages, workloads, and resources on premise and in the cloud + Document processes and methodologies for test, deployment and maintenance to ensure scalability, ... teams during security incidents and participate in site security audits + Participate in Performance & Capacity Management exercises...holidays) on a rotational basis + Participation in Change Manager Role on a rotational basis + Excellent written… more
- Abbott (Minneapolis, MN)
- …May be consulted in the following areas: study design, site payments, site audits , local document review, study documents preparation, and submission to site ... diabetes from routine fingersticks. Summary Under the supervision of senior colleague/ manager (or delegate), the Associate Clinical Site Lead drives study execution… more
- Covenant Health Inc. (Knoxville, TN)
- …to ensure protocol compliance. Punctually submitting reports, suggestions and concerns to manager . + Participates in monitoring visits and audits by collecting ... controls and assurance measures by monitoring compliance with study procedures and GCP standards, conducting quality assurance audits as requested, working with… more
- Actalent (Lombard, IL)
- …including information such as lot number and drug vs. placebo. + Document laboratory data and adverse reactions, promptly notifying investigators and sponsors of ... recruitment status and clinical needs to investigators and Site Manager . + Build relationships with monitors from sponsoring companies...contacts for future trials. + Prepare study documentation for audits and assist auditors during audits . +… more
- Actalent (Raleigh, NC)
- …monitoring for complications, maintaining accurate records, and assisting with audits . Responsibilities + Perform venipuncture, specimen processing, vital signs, ... including information such as lot number and drug vs. placebo. + Document laboratory data and adverse reactions, notifying investigators and relevant parties of… more
- Actalent (Wilmington, NC)
- …including information such as lot number and drug vs. placebo. + Document laboratory data and adverse reactions, promptly notifying investigators and sponsors of ... recruitment status and clinical needs to investigators and Site Manager . + Build relationships with monitors from sponsoring companies...contacts for future trials. + Prepare study documentation for audits and assist auditors during audits . +… more
