- Cedent Consulting Inc. (Boston, MA)
- Clinical Trial Project Manager (Boston, MA) Hybrid role About the Role As a Clinical Trial Project Manager , you will lead end-to-end ... We're Looking For Experience: At least 10 years in clinical trial project management, with...(CCRC) Certified Clinical Research Associate (CCRA) Certified Clinical Project Manager (CCPM) by… more
- Canfield Scientific, Inc (Parsippany, NJ)
- The ideal candidate for our Clinical Outcome Technology Project Manager position has great communication skills, is self-motivated and passionate about their ... ensures that digital platforms for patient-reported outcomes (PROs), electronic clinical outcome assessments (eCOA), and other trial ...deployment of in-house eCOA and PRO systems across global clinical trials Collaborate with clinical … more
- Crinetics Pharmaceuticals, Inc. (San Diego, CA)
- …Familiarity with risk-based TMF management approaches.* Experience in global/multi-regional clinical trial environments.* Strong project management ... leads to promote a culture of inspection readiness across the clinical trial portfolio.**Essential Job Functions and Responsibilities:**These may include… more
- University of California San Diego (San Diego, CA)
- …seeks a Manager of Regulatory Affairs to oversee compliance and support clinical trials . This leadership role demands extensive regulatory knowledge and the ... and mentor a diverse team. Candidates should possess strong project management skills and experience in clinical ...strong project management skills and experience in clinical research. The position offers a hybrid work schedule… more
- Syneos Health, Inc. (Houston, TX)
- A leading biopharmaceutical solutions organization is seeking a Project Manager I to support cell & gene therapy trials , focusing on operational oversight ... cross-functional coordination. The ideal candidate will have 2-4 years of clinical trial experience, especially in oncology or CAR-T studies. This role offers… more
- Stryker Group (Fremont, CA)
- …and portfolio strategy and, 2. managing the people and process to execute clinical trials and projects. This includes partnering with both external (study ... will be accountable for study planning, execution and close out (end-to-end Clinical project management). Ensures strategic alliances with monitors, core… more
- Stryker Corporation (Fremont, CA)
- …and portfolio strategy and, 2. managing the people and process to execute clinical trials and projects. This includes partnering with both external (study ... will be accountable for study planning, execution and close out (end-to-end Clinical project management).* Ensures strategic alliances with monitors, core… more
- NCBiotech (Raleigh, NC)
- …a step beyond through research, development and delivery of life‑changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy… more
- The Antibody Society (Princeton, NJ)
- …surveillance and escalation management. Cross-functional Collaboration Collaborate with Trial Management, Medical, Biomarker Operations, Clinical Programming, ... 3-5 years in oversight and leadership roles. Strong understanding of end-to-end trial conduct. Strong Project Management capability. Strategic planning and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to deliver future-state capabilities which lead to robust, scalable solutions to support clinical trial activities and that align to IT enterprise strategy and ... Operations, information technology groups to enhance and improve clinical systems and infrastructure. As a manager ...with Veeva's clinical solutions. Extensive knowledge in clinical trial operations and processes. Provide technical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to deliver future-state capabilities which lead to robust, scalable solutions to support clinical trial activities and that align to IT enterprise strategy and ... Operations, information technology groups to enhance and improve clinical systems and infrastructure. As a manager ...Connect, EDC etc.,) is a must. Extensive knowledge in clinical trial operations and processes. Minimum of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …our strategic vision for advanced analytics, with the goal of optimizing clinical trials , enhancing data-driven decision-making, and providing support for ... Sr Manager , Data Scientist United States - California -...that directly support strategic initiatives in areas like RWE, Clinical Pharmacology, and Biomarkers. Project Skills: Ability… more
- Syneos Health, Inc. (Hartford, CT)
- …train junior staff. Identify and communicate out of scope activities to Lead CRA/ Project Manager . Proactively suggest potential sites based on local knowledge of ... that enhance quality monitoring and support the overall success of clinical trials . Impact and ContributionIndividual contributors with responsibility in… more
- Syneos Health, Inc. (Trenton, NJ)
- …train junior staff. Identify and communicate out of scope activities to Lead CRA/ Project Manager . Proactively suggest potential sites based on local knowledge of ... follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical ...enhance quality monitoring and support the overall success of clinical trials . At Syneos Health, we are… more
- Cedent Consulting Inc. (Pleasanton, CA)
- …designed and developed with regulatory compliance in mind. Collaborate with the medical and clinical teams to ensure clinical trial protocols align with ... Manager /Director Regulatory Affairs - Pleasanton, CA In This...requirements and assist in preparing regulatory submissions to support clinical trials and device approval. Collaborate with… more
- Abbott Laboratories (Santa Clara, CA)
- …work closely with the Clinical Engineering and Medical Affairs for TAVI clinical trial training alignment. This position is US based and spends significant ... outcomes that advance the standard of care. This senior manager position is responsible for leading a team to...Skills. Create alignment between global stake holders (training, R&D, clinical science, medical affairs, clinical operations, KOL… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …approval. This position requires a comprehensive knowledge of CDISC standards, clinical trial study design, and electronic data submission requirements. ... SAS code or macros for preparing, processing, and analyzing clinical data. Interact with members of project ...of summary tables, data listings, and graphs required for trial reports and clinical development, and CDISC… more
- Syneos Health, Inc. (New York, NY)
- …train junior staff. Identify and communicate out of scope activities to Lead CRA/ Project Manager . Proactively suggest potential sites based on local knowledge of ... processes that enhance quality monitoring and support the overall success of clinical trials . Impact and Contribution Individual contributors with responsibility… more
- Exelixis, Inc. (Alameda, CA)
- …PURPOSE:**Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and ... Regulatory Affairs Strategy Manager (Oncology) page is loaded## Regulatory Affairs Strategy...preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission progress, and… more
- Crinetics Pharmaceuticals, Inc. (San Diego, CA)
- …MS Word and Adobe PDF knowledge required.Preferred:* Additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) ... Regulatory Affairs Manager page is loaded## Regulatory Affairs Managerremote type:...a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with… more
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