- Novo Nordisk Inc. (West Lebanon, IN)
- …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 Inc. (West Lebanon, IN)
- …deviation investigation approaches are appropriate and suitable to the business's operations and communicating and escalating deviation priorities, risks, and ... CAPA that reduce recurrent deviation types Lead and supervise the deviation investigation team, assign deviations based on investigator skill/experience and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.Note that vendor management is not limited to the ... bring deviations to the supervisor. Review and approve Vendor invoices, including investigator grants and pass-through costs.Provide oversight of the CRO to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to internal procedures… 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 ... with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect… more
- 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
- 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …direction of the Head of Operations and the Head of Quality Systems, the Deviation Investigator will play a pivotal role in our company's growth by owning ... and investigating all Manufacturing-related deviations. The Deviation Investigator will collaborate with cross-functional stakeholders to perform simple and… 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
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …of my knowledge. **Job Description** **About the role:** The Lead Investigator will initiate and complete deviations to support Manufacturing. Responsibilities ... to the manufacturing functions which includes filling, inspection, and packaging operations . Also, you will work with the corresponding manufacturing, 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 / ... to make life better for people around the world. ** Operations Manager** **-** **DAP** At Lilly, we unite caring...and mindset - lean, six sigma, etc. + Documentation, deviation and change management systems (eg, Trackwise. Veeva QualityDocs,… more
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... people around the world. **Responsibilities:** During the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training. + Note that vendor management is not limited to ... and bring deviations to the supervisor. Review and approve Vendor invoices, including investigator grants and pass-through costs. + Provide oversight of the CRO to… more
- Lilly (Durham, NC)
- …housekeeping procedures are maintained. + Quality - Responsible for Warehouse and ILS operations and meeting the quality standards as defined by cGMPs, the Global ... Also, should be trained to perform TrackWise activities such as Lead Investigator , Change Owner, Action Planning, and Work Item implementation. Maintain quality… more
- Novo Nordisk (Lexington, MA)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, ... Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications… 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
- 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
