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Job vor 14 Tagen gefunden

Continuous Improvement (MVP) Leader

• Frankfurt, Hesse Führungs-/ Leitungspositionen SHIFT: Day shift, Monday- Friday 8:00 AM to 5:00 PM. Subject to change according to business needs. BENEFITS: We proudly offer a comprehensive benefits package,[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] to identify MVP training needs for the plant and to deliver training solutions on MVP tools and processes. Ensure all plant employees have opportunities for engagement and ownership in MVP programs and activities. Act as the champion and subject matter expert for Root Cause Analysis. Act as the subject matter expert for Early Management processes and tools. Partner with Operations to sustain daily review and communication process through continual coaching and auditing. Champion One Right Way initiatives, including education, center lining and rate- lock, standard work documents, and systems. Personally lead teams utilizing MVP processes. Provide leadership and direction to all employees through direct [...]

Job vom 20.03.2025

Global Head of Early Development Biometrics

• Basel, Basel- Stadt Führungs-/ Leitungspositionen We advance science so that we all have more time with the people we love. The Opportunity As the Global Head of Early Development Biometrics,[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] the impact you have) , fostering a culture of learning, growth, and continuous improvement that empowers team members to reach their potential. Define and create clear accountability across each function in your organization and beyond, ensuring that you work in lock- step with your colleagues and partners to maintain alignment and drive cross- functional collaboration. Leadership and Strategy Provide strategic leadership [...] leaders across a global organization, driving strategy and execution with key stakeholders. Develop and implement a comprehensive integrated Biometrics strategy with a lens of early development and data science excellence that aligns with Roches research and early development objectives. Provide expert guidance to clinical development teams on study design, statistical methodology, and key decision- making processes (e. g. , Piv Go) [...]

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Job vor 7 Tagen gefunden Bio Marin Pharmaceutical Inc.

Associate Medical Director, Clinical Science

• London, Greater London, United Kingdom, London (Greater) Führungs-/ Leitungspositionen Description Who We Are Bio Marin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] Science Communication and Collaboration Serve as CLS representative and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed Clinical Study Monitoring Act as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk Initiate and provide [...] issues, prepare content and facilitate discussions at study Data Review Board (internal) or Data Monitoring Committee (DMC) Lead the selection of and interactions with independent Data Monitoring Committees (DMC) Participate in and provide scientific advice, as appropriate, during key Database Lock (DBL) activities (final listing review, review of blinded tables, listings and figures (TLFs) , etc. ) and actively participate in [...]

Job vor 8 Tagen gefunden Alnylam Pharmaceuticals

Manager, Clinical Operations Study Start- Up

• Cambridge, Massachusetts, United States, Cambridge Alnylam Pharmaceuticals is seeking a Manager, Study Start- up to join our dynamic and growing team. The Manager, Study Start- up partners closely with the[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] Start- up provides direct oversight, direction, and support beginning at early study planning, country and site selection, feasibility, data- driven scenario planning, and enrollment forecasting to ensure predictable and consistent delivery. The Manager, Study Start- up will serve as an expert across the study start- up, country, and site activation landscape. The Manager, Study Start- up practices efficient implementation and oversight [...] remove or prevent roadblocks Facilitates prompt risk resolution to remediate issues immediately by utilizing site and country intel, internal and external expertise to remove and prevent roadblocks Analyzes competitive trial performance data and industry benchmarks to support the Clinical Operations lock of baseline study milestones targets/ dates; partners with CRO and internal Expertise Areas to harness historic study/ site performance data [...]
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Job vor 11 Tagen gefunden Takeda Pharmaceutical Company Limited

BST and Clinical Biomarker Lead, Neuroscience, Associate Director

• Boston, Massachusetts, United States, Boston Führungs-/ Leitungspositionen By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] , including study protocols, regulatory documents and communications (IND, NDA, BLA, PMA, etc. ) , Briefing Book (BB) , Investigatory Brochure (IB) , Clinical Study Reports (CSR) , study start up (e. g. ICF, data transfer agreements) and data base lock activities (e. g. sample reconciliation, data review/ QC and transfer) , etc. Leads BST sub team of subject matter and [...] development and implementation in neuroscience TA with 10+ years experience in the biotechnology or pharmaceutical environment. Solid understanding of bioanalytical and biomarker strategies, applicable regulatory guidance, clinical trials, endpoints and deliverables. Leadership The incumbent will serve as a subject matter expert on BST teams helping drive scientific excellence, strategic, tactical and fiscally responsible operations in support of BST and programmatic goals. [...]
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Job vor 12 Tagen gefunden Takeda Pharmaceutical Company Limited

Senior Manager, Clinical Data Management (Oncology)

• Massachusetts, United States By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application[...]

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[...] solving that align with the Takeda values. They establish Project or Program level strategies and services, and are responsible for the management of vendor partnerships to maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management serves as an expert for clinical data management, whether directly or by way of managing or mentoring other junior CDM Staff. They will lead [...] suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/ or cross- functional teams. For studies where data management activities are conducted within Takeda, leads and manages clinical trial data collection set- up, data review, and database lock: Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO [...]
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Job vor 14 Tagen gefunden Regeneron Pharmaceuticals, Inc.

Senior Manager Clinical Study Lead

• United Kingdom Führungs-/ Leitungspositionen The Senior Clinical Study Lead (CSL) is expected to operate with high- degree of independence and is accountable for the global execution of assigned large[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close- out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and [...] training and compliance, and study support/ oversight May require 25 travel This role may be for you if you have: Exceptional interpersonal leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation [...]

Job vom 08.03.2025 Ipsen Pharma

Senior Manager, Biostatistics f/m

• London, United Kingdom, London (Greater) Title: Senior Manager, Biostatistics f/m Company: Ipsen Innovation (SAS) About Ipsen: Ipsen is a mid- sized global biopharmaceutical company with a focus on transformative medicines[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] broad statistical support and contributing strategically to project decisions, with a focus on clinical planning, study design, protocol development, sample size/ power calculations and simulations, statistical analysis methodology, statistical analysis plan preparation, blinded in- trial data quality review, pre- database lock data quality control, supporting development of table/ listing/ figure templates, programming and production, oversight of contract or CRO resources, as well as preparation, integration and documentation of clinical regulatory submission package, in accordance with CDISC standards. is expected to act independently as the statistics subject matter expert for all clinical development programs and studies, while ensuring adherence to all regulatory requirements. Responsabilities The Sr Manager of Biostatistics [...]

Job vom 07.03.2025 Precision for Medicine

Principal Clinical Scientist, Clinical Science Analytics Insights

• London, Greater London, United Kingdom, London (Greater) Precision for Medicine are recruiting an experienced Principal Clinical Scientist to work remotely in Poland, Hungary, Serbia, Romania, Slovakia, Spain or UK. Position Summary: The[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] Specialist must have a strong working knowledge of medical and oncology standards applicable to clinical trials, preferably in the are of solid and liquid tumors. Principal Clinical Scientist manages the operational clinical science function from study start up through database lock for assigned projects focused on the scientific indication specific insights into data collection data visualization outputs to support scientific, clinical- sense data cleaning as part of Precision s cross- functional data review team. Serves as the subject matter expert in the application of clinical knowledge, guidelines standards of care to the review of clinical trial data. Medical related degree [...]

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Handwerk, Gewerbe, Landwirtschaft Anlagenmechanik, Anlagentechnik, Schlosser

Dauer: 0.1877 s., Vers. V.2025-a-2004-Ind-141