- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... the protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and… more
- Merck & Co. (Rahway, NJ)
- …execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team ... the protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality, completeness , and… more
- Eisai, Inc (Nutley, NJ)
- …Operations is a senior leadership role responsible for overseeing all aspects of clinical trial execution within a pharmaceutical or biotechnology company. This ... This role requires a deep understanding of the entire clinical trial process, from initial planning and...other stakeholders to ensure alignment and successful execution of clinical trials. Monitor study progress, identifying and mitigating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document submission.ResponsibilitiesSupport audit ... program for clinical studies and vendors as applicable for the area...post marketing stakeholders for key Health Authority pre-approval and sponsor- monitor inspections; provide inspection management support and follow-up activities… more
- Edwards Lifesciences Corporation (Dallas, TX)
- …/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial /study safety, in keeping with protocols, GCP ... Monitor to join Edwards Aortic Field Monitoring team. As a Senior Clinical Research Monitor , you ensure trial patients' safety by assuring trials are… more
- Syneos Health Careers (Morrisville, NC)
- Description Clinical Trial Manager - Real World Late Phase Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built to ... monitor and report on the status of the trial Ensure compliance with applicable regulations globally and by...degree preferred Minimum of 5 years of experience in clinical trial management, with a focus on… more
- SystImmune, Inc (Redmond, WA)
- … visit completion to trigger payments. Financial Reporting & Analysis: Prepare monthly clinical trial cost reports and variance analyses. Support quarterly and ... clinical trials, including preparing invoices approval package, tracking trial costs, and ensuring compliance with internal controls and...year-end financial close processes. Maintain trial -level tracking tools to monitor spending and… more
- Ipsen (Cambridge, MA)
- …other study team members. Make appropriate and timely reporting in CTMS (Ipsen's Clinical Trial Management Tracking System), with regular checks for quality and ... the defined timelines without jeopardizing the start of a trial . Support the Clinical CRO in the...and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other… more
- Kaiser Permanente (Panorama City, CA)
- …in the training of new team members and/or clinical staff. If assigned to clinical trial , may work with Sponsors/ monitors at clinical sites. Adheres to ... confidentiality requirements and standards. Adheres to GCP and compliance regulations for clinical trials. Assists with and/ or oversees quality assurance of study… more
- Mount Sinai Hospital (New York, NY)
- …Project Manager II will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration (CRSC) within the ... organization. This role involves coordinating all aspects of trial management, ensuring compliance with regulatory requirements, and facilitating collaboration among… more
- Qpex Biopharma, Inc (San Diego, CA)
- …as primary Sponsor medical point of contact (eligibility questions, AE management, etc) for clinical trial sites and CRO Present clinical study outcomes and ... Contribute to development of CRFs and data review plans Monitor , analyze and review data in ongoing studies Serve...development preferred Infectious disease training and/or practice a plus Clinical trial design and management experience Strong… more
- Samsung Research America (Mountain View, CA)
- …FDA, and HIPAA requirements Experience with statistical software Experience with clinical trial documentation, SOPs, and safety monitoring Special Attributes: ... full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research… more
- Duke University (Durham, NC)
- …Occupational Summary Participates in or leads day to day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; performs a ... variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or… more
- Kyowa Kirin North America (Princeton, NJ)
- …company experience. *Minimum 2 years' people management experience *Multi Regional Clinical Trial experiences *Experience in hematological cancers or ... on Project Teams; Review protocols, statistical analysis plans, monitoring guidelines and Clinical Study Reports; Work closely with Medical Monitor (s) to review… more
- Positive Solutions Behavior Group, LLC (Dayton, OH)
- …appropriate and ensure comprehensive dissemination of information to staff and families Monitor clinical systems, quality checks, adherence to policies and ... sciences and services in the community, home, schools, and clinical setting. We are seeking a candidate who shares...training programs for RBTs seeking BCBA supervision. Review and monitor billing, CPT codes, and contractual obligations to funders… more
- The University of Pennsylvania (Philadelphia, PA)
- …Understanding interaction of Medicare regulations and/or third-party insurance to develop clinical trial budgets. Preparing financial analyses, as necessary, and ... and wellness programs and resources, and much more. Posted Job Title Manager, Clinical Research Finance Operations (Office of Clinical Research) Job Profile… more
- Torrey Pines Solutions (San Francisco, CA)
- …of Clinical Operations strategy. *Oversee execution of department strategy. * Monitor execution of processes to determine points of failure. *Identify and ... About the job Associate Director, Clinical Operations Key Responsibilities * Team Management -...bringing together a team of internal stakeholders as a trial /product design and plans are being built out. *Contribute… more
- CW Bill Young Department of Veterans Affairs Medical Center (Cape Coral, FL)
- …in written and spoken English. You may be required to serve a trial period. Subject to background/security investigation. Selected applicants will be required to ... agency, and the degree is found to be equivalent to a NAACLS-approved US clinical laboratory science degree program. OR The applicant submits a letter from ASCP BOC… more
- Nuvalent, Inc. (Cambridge, MA)
- …products could address unmet needs *Collaborate with clinical development and clinical operations to identify clinical trial sites/investigators and ... support patient enrollment in our company's sponsored clinical trials *Deliver approved medical/scientific presentations to internal and external stakeholders *Act… more
- IQVIA, Inc. (Durham, NC)
- …to establish project objectives and timelines. Write the statistical sections of clinical trial protocols, while consulting with internal and external experts. ... Write statistical analysis plans. Monitor internal and CRO project activities including timelines, deliverables,...industry experience. At least 3 years in Phase 2/3 clinical trial experience. Demonstrated ability to work… more
