- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Merck & Co. (Rahway, NJ)
- …The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable...and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). Contribute to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, ... and Figures (TLFs) generated by vendor , ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and ... with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and...complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …skills preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO ... Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...other vendor performance against project goals and milestones to monitor… more
- IQVIA (Boston, MA)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor ... management becomes the catalyst for advancing medical breakthroughs. As a ** Clinical Trial Vendor Manager ** , you'll play a key role in our clinical … more
- Ascendis Pharma (Palo Alto, CA)
- …skills. Responsibilities: + Plan, drive and coordinate operational aspects of clinical trial execution from initiation, planning, execution, maintenance and ... for meeting corporate and departmental goals related to a clinical trial ; delegate specific activities to Regional...identify potential risks and resolve issues with CROs; establish vendor management plans and review quality metrics. + Plan… more
- ICON Clinical Research (PR)
- As a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare ... **What you will be doing:** + Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership… more
- Amgen (Washington, DC)
- …best work alongside other innovative, driven professionals in this meaningful role. **Local Trial Manager (LTM)** **Live** **What you will do** Let's do this. ... internal and external partners to ensure timely delivery, budget implementation of clinical trial results within the local country. **Key Activities:** +… more
- ThermoFisher Scientific (Greenville, NC)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... execute high-quality, cost-efficient clinical studies. As a Clinical Team Manager (CTM)/ Local Study ...content and quality of the relevant sections of the Trial Master File (local and central). - May participate… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …a Bachelor's Degree and minimum of 8 years of experience and success in a clinical trial /life sciences management role. Experience working with clinical drug ... The Senior Manager Development Operations & Portfolio Management (DO&PM) Vendor & Relationship Management (VRM) position is responsible to ensure that… more
- AbbVie (North Chicago, IL)
- …(and statements of work) in assigned categories as requested by management. For Vendor Managers that support clinical trial related services, partners ... countries, value generally exceeds $10 MM annually, multiple TA/FAs utilizing) vendor relationships and transactions with high complexity. Leads negotiations and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...collaborations + Applies advanced negotiation and interpersonal skills to vendor management + Advanced technical proficiency in trial… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...to build productive study teams and collaborations + Demonstrated vendor management experience + Technical proficiency in trial… more
- Novo Nordisk (Lexington, MA)
- …development experience in the pharmaceutical industry + At least 3-5 years of experience as a Clinical Trial Manager + Experience with global clinical ... The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a...Senior CPM will be responsible for all aspects of clinical trial management aimed at treating a… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and services in more than 110 countries and regions. **Summary:** Manages clinical trial studies for specific therapeutic area(s). Provides guidance and ... / leadership role preferably in a pharmaceutical company. Advanced leadership and clinical trial /project management experience in managing study teams, vendors,… more
- IQVIA (Wayne, PA)
- … team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set[1]up and coordination of ... Is primary point of contact for the assigned Project Director/ Manager from the CRO responsible for the trial...in Life Sciences. * Minimum of 8 years of clinical trial experience in the pharmaceutical industry… more
- Bristol Myers Squibb (Princeton, NJ)
- …projects * Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects * ... database Lock . **Position Summary / Objective** The Senior Manager , Clinical Data Management is a leadership...multi-disciplinary project teams and develop productive relationships with external vendor s + Sound knowledge of Clinical … more
