- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for assigned ... and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability… more
- Abbott (San Diego, CA)
- …quality standards. + Supervise and manage electronic data capture (EDC) systems and electronic trial master file (eTMF) platforms to ensure data integrity ... working mothers, female executives, and scientists. **The Opportunity** The **Clinical Trial Manager ** works out of our **San Diego, CA** office location in… more
- Actalent (Menlo Park, CA)
- …communication with site staff and pharmaceutical partners (as applicable). . Ensures electronic Trial Master File (eTMF) is current and maintained Skills ... remote (hybrid role) + Ability to run a full trial (start up, maintence, close out) independently + Experience...delivery of clinical studies. . Supports and guides Clinical Trial Managers and Clinical Project Assistants ensuring alignment of… more
- GRAIL (Menlo Park, CA)
- …communication with site staff and pharmaceutical partners (as applicable). + Ensures electronic Trial Master File (eTMF) is current and maintained **Required ... companies. For more information, please visit grail.com . The Sr. Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the… more
- ThermoFisher Scientific (Wilmington, NC)
- …Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Act as the Subject Matter Expert and primary point of accountability and reconciliation for the Trial Master File (TMF) and the Investigator Site File ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Clinical Trial Coordinator (Sr. CTC) will be responsible for supporting the… more
- Actalent (New York, NY)
- …and third-party payments. + Ensure required study documents are submitted to the CRO-held electronic Trial Master File (eTMF). + Assist the CPM with Sponsor ... The Clinical Trial Associate (CTA) will play a vital role...Responsibilities + Generate agendas and minutes, maintain study tracking, file and conduct quality reviews, and participate in process… more
- ThermoFisher Scientific (Wilmington, NC)
- …review (including appendices)** **Collect/review/ File study documents in support of the trial master file (TMF)** **Collect/review/ File study ... (Mon-Fri) **Environmental Conditions** Office **Job Description** **CSM (Clinical Study Manager ):** **OBJECTIVES:** **Lead or support study operational strategy and… more
- Taiho Oncology (Princeton, NJ)
- …study closeout related activities and trial completion. + Overall responsible for the Trial Master File , including review of the TMF plan, related ... global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical studies are delivered within… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical ... masked investigational product, set up and management of unmasked trial master file , review of...performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and… more
- Edwards Lifesciences (Chicago, IL)
- …and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file ), and Microsoft Project + Excellent written and ... and be part of our inspiring journey. **As the Manager of Clinical Project Management** , you will manage...requires the ability to synthesize large sets of clinical trial data to support innovative operational strategies. The ideal… more
- Mount Sinai Health System (New York, NY)
- …event documentation, safety reporting, and correspondence with IRBs and sponsors. + Maintain the Trial Master File (TMF) and site investigator files in ... **Job Description** The **Clinical Trial Manager ** provides leadership and oversight...related scientific/health field (life sciences, health administration, etc) required. Master 's degree or equivalent advanced training in clinical research… more
- ICON Clinical Research (Blue Bell, PA)
- …of IP supply activities is provided to clinical trial teams for the Trial Master File . Provides input to drug kit randomization specifications and ... Clinical Drug Supply Manager ICON plc is a world-leading healthcare intelligence...according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment… more
- Kelly Services (West Point, PA)
- …and maintaining project schedule and collaborating with Program Lead + Sets up and maintains Trial Master File (eTMF) + Ensures alignment of budget with ... **Senior Study Manager I** **Therapeutic Areas: Oncology & Immunology** **Description...for the following: + Operational point of contact for trial execution and all trial deliverables +… more
- Stanford University (Stanford, CA)
- Cancer Clinical Research Manager - GI Oncology (Hybrid) **School of Medicine, Stanford, California, United States** **New** Research Post Date 4 days ago Requisition ... # 107873 Stanford Cancer Institute - Clinical Trials Office - Clinical Research Manager - GI Oncology (Hybrid Work Schedule) The Stanford Cancer Institute (SCI) was… more
- BeOne Medicines (San Mateo, CA)
- …Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular ... on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** As the **Sr. Manager , Biostatistics** you will lead biostatistical analysis and reporting, document review ... limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring… more
- City of Norfolk, Virginia (Norfolk, VA)
- …are not limited to: Assistant Commonwealth's Attorney I: + Prepares cases for trial by reviewing case reports, identifying the relevant facts of the case, contacting ... conducts transfer and certification hearings. Complies with office policies regarding file documentation after District Court, preparation of documents for Grand… more
- ThermoFisher Scientific (Wilmington, NC)
- …Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve… more
- Albany Medical Center (Albany, NY)
- …by reviewing with defense counsel semi-annually * Track the litigation, anticipate trial dates, discovery dates, disclosure dates, etc. in accordance with Litigation ... and external to the office for related ligation meetings, pre-depositions, depositions, trial related Data Management: + Assumes day to day responsibility for data… more
