- Takeda (Boston, MA)
- …negotiations, financial analysis and budget management. Familiarity with CRO and clinical outsourcing models, including financial and commercial constructs. ... therapies to patients worldwide. Objective / Purpose The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by… more
- Softworld (Waltham, MA)
- …company that caters to the life sciences industry. We specialize in offering clinical data analytics solutions and functional outsourcing services. Our team is ... proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and PK/PD analysis.… more
- Takeda (Boston, MA)
- …best of my knowledge. Job Description About the role: The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of ... process in partnership with functional compliance teams for regulations impacting Clinical , Safety and Clinical Pharmacovigilance Medical Quality (CPMQ)… more
- CSL Plasma Inc. (Waltham, MA)
- Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins X2 page is loaded## Associate Director Clinical Assay Strategy Transplant ... the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of… more
- CSL Plasma Inc. (Waltham, MA)
- Associate Director Clinical Assay Strategy, Hematology and Cardiovascular & Renal page is loaded## Associate Director Clinical Assay Strategy, Hematology and ... the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of… more
- Revolution Medicines (Redwood City, CA)
- Revolution Medicines is a clinical -stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS‑addicted ... The Opportunity The COST‑Vendor Senior Manager supports the end‑to‑end outsourcing of external service providers for current and future... of external service providers for current and future clinical trials for Clinical Vendors (eg, CROs,… more
- Slipstream IT, LLC (Trenton, NJ)
- …proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth. ... activities for all GxP-related computerized systems used in manufacturing, laboratory, clinical , and quality operations. Regulatory & Standards Scope This position… more
- Cytokinetics (San Francisco, CA)
- …your deep toxicology knowledge and industry experience to design and manage non- clinical safety studies, provide strategic input to project teams, and ensure the ... colleagues in Discovery Biology, Pharmacology, Medicinal Chemistry, DMPK, CMC and Clinical to drive our programs forward.Your strong analytical skills, decisiveness,… more
- argenx SE (Boston, MA)
- …in nonclinical safety testing, operations of regulated studies and nonclinical and clinical Bioanalytics. We closely work with our colleagues from other functional ... at the heart of argenx discovery and development. argenx works via a strong outsourcing model where scientific and quality oversight from the sponsor is an important… more
- Dyne Tx (Waltham, MA)
- …(CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), ... Management of external quality operations in support of GMP manufacturing ( clinical and commercial) activities. Manage deviations, OOS and OOTs investigations while… more
- argenx SE (Boston, MA)
- …in nonclinical safety testing, operations of regulated studies and nonclinical and clinical Bioanalytics. We closely work with our colleagues from other functional ... at the heart of argenx discovery and development. argenx works via a strong outsourcing model where scientific and quality oversight from the sponsor is an important… more
- Allergan (Greenlawn, NY)
- …stakeholders. You will also partner with key collaborators, incl. Clinical , Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations. ... within the approved funding. Driving legal and financial aspects of outsourcing , contracts, and statements of work (SOW). Demonstrating excellent interpersonal… more
- The Antibody Society (Chicago, IL)
- …functions and stakeholders. You also partner with key collaborators-including Clinical , Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial ... staying within approved funding. Driving legal and financial aspects of outsourcing , contracts and statements of work (SOW). Demonstrating excellent interpersonal… more
- TechDigital Group (Foster City, CA)
- …as well as part of a team Preferred: Knowledge of the clinical research space. RFP management and vendor oversight experience. Responsibilities: Work with ... project plans, timelines, and budgets for data initiatives. Manage vendor outsourcing space, including managing RFPs and vendor relationships. Coordinate with… more
- Takeda Pharmaceuticals (Boston, MA)
- …negotiations, financial analysis and budget management. + Familiarity with CRO and clinical outsourcing models, including financial and commercial constructs + ... life-changing therapies to patients worldwide. **_Objective / Purpose:_** The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of … more
- Sumitomo Pharma (Olympia, WA)
- …with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing , and/or CRO relevant ... Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage… more
- Teva Pharmaceuticals (West Chester, PA)
- …develops high-performing clinical trial management teams Review and approve clinical outsourcing specifications + Oversee management of the CROs, vendors, ... Sr. Director, Global Clinical Operations TA Head, Neuroscience Date: Jan 6,...lead the strategic and operational global execution of all clinical trials within the Neuroscience TA. This leadership role… more
- Actalent (North Chicago, IL)
- …Degree with a minimum of 1 year of relevant experience. + Experience in clinical research, Finance, Outsourcing , Accounts Payable, or equivalent is preferred. + ... Job Title: Clinical Contract Documentation Specialist IIIJob Description The Clinical Contract Documentation Specialist III will be responsible for processing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …skills with counterparts in other functional teams (eg, Biomarker Sciences, Vendor Outsourcing , Clinical Operations, and Data Management) to ensure efficient ... Join Gilead and help create possible, together. **Job Description** Clinical Operations is responsible for the worldwide execution of...the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical… more
- Actalent (North Chicago, IL)
- …Clinical Study process is preferred. Preferred Experience + Experience in clinical research, finance, outsourcing , accounts payable, or equivalent. + ... the Role This role is responsible for processing vendor agreements and Clinical Study Agreements (CSAs) into the contracting database, ensuring all auditable… more
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