- Curia (Albuquerque, NM)
- …processing steps. + Provides consistent direction and timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will ... The investigation owner will lead the investigation of deviations that occur in operations . Author and manage the inquiries to meet key timing commitments with… more
- Novo Nordisk (West Lebanon, NH)
- …your career. Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations ... the technical merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations… more
- Novo Nordisk (West Lebanon, NH)
- …deviation investigation approaches are appropriate and suitable to the business's operations and communicating and escalating deviation priorities, risks, and ... that reduce recurrent deviation types + Lead and supervise the deviation investigation team, assign deviations based on investigator skill/experience and … more
- Merck (West Point, PA)
- …Description** **Job Description** We are seeking a Growth and Improvement minded Deviation Management investigator that can help drive our Strategic Operating ... Us **Summary** As part of our Manufacturing Division, Polysaccharide Vaccines Technical Operations at West Point is seeking a highly motivated individual to partner… more
- Lilly (Branchburg, NJ)
- …determined to make life better for people around the world. The Root Cause Investigator will serve as a primary investigator for site investigations into Quality ... root cause, and corrective/preventive actions needed to prevent recurrence. The Root Cause Investigator also serves as a trainer and mentor to the functional area… more
- Endo International (Rochester, MI)
- …knowledge and experience in Quality Management Systems such as change management, deviation investigation, and CAPA. The Operations Support Technical Writer will ... for talented individuals to join our team. **Job Description Summary** The Operations Support Technical Writer, with support of Site Leadership, sponsors a quality… more
- University of Colorado (Aurora, CO)
- …nurses, clinic support staff, laboratory, pharmacy, radiology). + Plans and directs investigator and coordinator meetings including but not limited to team meetings, ... + Collaborates with OCRST, Oncology Clinical Research Support team on Investigator Initiated trials. + Serves as primary clinical research coordinator and… more
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... Concord, North Carolina which will house warehousing & logistics, parenteral operations , medical device assembly, and packaging, QC laboratories, and support teams… more
- Bristol Myers Squibb (Bowdre, IL)
- …(APIs and Excipients). **Deviations and laboratory investigation management:** + Act as Deviation Owner or lead investigator for QC incoming packaging ... Provide appropriate level of reporting and communication on the assigned deviation /lab investigations at Quality governance forums. + Present deviations in… more
- Bristol Myers Squibb (Devens, MA)
- …key stakeholders, such as Manufacturing Science and Technology, Quality, Manufacturing Operations , and Validation. **Major Duties & Job Responsibilities:** + Gain a ... at Devens Cell Therapy Facility (CTF) at Devens campus. + Act as a deviation author for deviations related to computerized systems (DeltaV, Syncade, PI, Benchtop IT… more
- University of Miami (Miami, FL)
- …of specific clinical research studies. This roleassists in the day-to-day operations of clinical research protocol implementation and carries out study coordination ... in the LEO (Lymphoma Epidemiology and Outcomes) protocol. Works with principal investigator to determine eligibility. 2. Retrieve required lab and tissue specimens… more
- IQVIA (San Antonio, TX)
- External Job Description: Ensures safe and effective operations of clinical research studies. Safeguards the wellbeing of research subjects in a medical capacity; ... accordance with the Health and Safety policies. Serves as sub- Investigator for clinical research studies conducted by a supervising...the delivery of care to the volunteer Report any deviation from normal practice to senior staff. * Review… more
- Catalent Pharma Solutions (Bloomington, IN)
- …appropriate corrective and/or preventive actions (CAPA) to prevent reoccurrence. The Investigator assists Operations and Quality Assurance teams to determine ... the initial triage and RPN score of each assigned deviation investigation to ensure it aligns with the company...addressed. + Completes all investigation information into a comprehensive deviation report in a manner that clearly defines the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard ... meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. + Support Fair Market Value process in evaluating study… more
- University of Washington (Seattle, WA)
- …and Classical Hematology disease group faculty to facilitate investigator -initiated and industry-sponsored clinical trials. Position Complexities This position ... protocol requirements and identify protocol procedures that will impact clinic operations . + Participate in clinical implementation of research activities at UWMC… more
- University of Washington (Seattle, WA)
- …the School of Medicine and the largest non-divisioned department. The overall annual operations funding from all sources is over $130 million. **The Department of ... in this position will work under the supervision of the Principal Investigator , Dr. Kristen Lindgren, co-director of Trauma Recovery and Resilience Innovations, on… more
- Robert Half Technology (Mayfield, KY)
- …+ Oversee the execution of validation protocols. + Act as Lead or Associate Investigator for deviation and OOS investigations. + Assist as a primary resource ... individual who assumes this role will be responsible for supervising quality operations , ensuring safe and high-quality product output that is consistent in… more
- Endo International (Rochester, MI)
- …+ Develop/Manage the Investigation Program : + Develop and implement an Investigator Certification Program. + Develop/Introduce tools to achieve Root Cause Analysis. ... deep understanding of Quality Management Systems (QMS), including change management, deviation handling, and CAPA processes. + Collaborate with Quality Assurance and… more
- Ascendis Pharma (Palo Alto, CA)
- …plans, such as Project Management Plan, Enrolment Plan, Monitoring Plan, Protocol Deviation Plan, etc. + Provide input to patient information/consent, eCRF forms and ... plans and review quality metrics. + Plan Monitor and Investigator Meetings and other training related activities for sites...equivalent) + Minimum 3 years of experience within clinical operations or related function + Experience with one or… more
- Beth Israel Lahey Health (Boston, MA)
- …of America) The Clinical Trials Monitor (CTM) monitors and audits the investigator -initiated clinical research studies across all disease groups in the Cancer ... to ensure regulatory compliance. (essential) + Manages Corrective Action Logs, Deviation Trending Logs, SOPs, GCLP Documents and personnel performance for accurate… more