Clinical Data Systems Manager

Join our dynamic team at Artech Information Systems LLC as a Clinical Data Manager. In this pivotal role, you will oversee the collection, management, and analysis of clinical data, ensuring accuracy and compliance with regulatory standards. Your expertise will drive the success of clinical trials and contribute to innovative healthcare solutions.

As a Clinical Data Manager, you will be pivotal in overseeing the management, integrity, and quality of clinical data. Your expertise will ensure that data collected during clinical trials is accurate, reliable, and compliant with regulatory standards. You will collaborate closely with cross-functional teams, manage data submissions, and provide insights for decision-making processes.

Thank you for your interest in the Manager II, Clinical Quality Assurance position at itcss! We encourage you to explore the details below. If you believe this role aligns with your career aspirations, please discuss with your current manager and HR business partner to assess your qualifications. Should everything align, we invite you to apply, and our Talent Acquisition team will reach out to you for an interview. We look forward to getting to know you!- Your Human Resources TeamAbout the RoleAs the Manager II of Clinical Quality Assurance, reporting to the Director of Clinical Quality Assurance, you will play a pivotal role in overseeing clinical quality support and the management of the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) supplier qualification program.The ideal candidate will be instrumental in preparing the company for inspections, providing training, and ensuring compliance with current ICH GCP E6 guidance and relevant regulations.Key Responsibilities:Deliver daily clinical quality support and training to ensure compliance with regulatory requirements and internal policies.Manage GCP/GLP/GVP internal and supplier audits, including maintaining the qualification program's audit schedule within the Quality Management System (QMS).Conduct supplier audits and prepare reports as necessary.Compile audit responses and evaluate implementation evidence.Assist in the development of quality systems and processes in the Clinical Quality domain.Review and approve QMS records (deviations, CAPAs, change controls, etc.) for completeness and adherence to SOPs and regulations.Support remediation and corrective action plans, ensuring resolution of quality issues.Assist in reviewing Clinical Quality Management Plans (CQMPs) for trials and vendor performance.Manage clinical training curricula and assist in creating tools to track quality metrics.Support risk assessments and conduct periodic reviews of clinical trial systems (e.g., CTMS, TMF).Collaborate with Quality Management to maintain compliance with various standards.

About the Role As a pivotal member of the Clinical Quality Assurance team, reporting directly to the Director of Clinical Quality Assurance, the Manager II will spearhead clinical quality support and the management of our comprehensive supplier qualification programs encompassing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP). The ideal candidate will play a crucial role in ensuring inspection readiness across the organization, providing training and guidance to maintain compliance with the latest ICH GCP E6 standards and relevant regulations. Key Responsibilities: Deliver daily clinical quality support and training to uphold adherence to regulatory requirements, company policies, and procedures. Oversee internal and supplier audits related to GCP/GLP/GVP, including the management of the audit schedule within the Quality Management System (QMS). Conduct supplier audits and prepare comprehensive reports as necessary. Compile responses to audits and assess evidence of implementation. Assist in the development and execution of quality systems and processes within the Clinical Quality domain. Review and approve QMS records for completeness and compliance with SOPs and regulations. Support the development of remediation plans and monitor the resolution of quality issues. Contribute to the review of Clinical Quality Management Plans (CQMPs) for clinical trials and vendor performance. Manage and enhance clinical training curricula. Support the creation of tracking tools for reporting quality metrics. Conduct and review Risk Assessments as required. Collaborate closely with Quality Management to ensure compliance with all applicable guidelines and SOPs. Act as a resource for Clinical Development, Operations, and Quality teams.

AbbVie Inc. is hiring a Senior Manager, Clinical Quality Assurance based in Irvine. This position leads quality assurance efforts within clinical development, focusing on compliance with regulatory standards and internal policies. Role overview This role manages the creation and execution of quality assurance strategies for clinical trials. The Senior Manager oversees a team of quality assurance professionals, providing direction as they conduct audits and inspections across clinical programs. Key responsibilities Develop and implement quality assurance strategies for clinical development activities Supervise and mentor a team of quality assurance staff Guide the team in performing audits and inspections to ensure compliance and data integrity Promote adherence to regulatory requirements and internal quality standards Requirements Extensive experience in clinical quality assurance Demonstrated leadership and team management skills Commitment to maintaining high standards in clinical trial execution

About the Role We are seeking a dedicated Clinical Trial Assistant (CTA) to facilitate the seamless execution of clinical research studies. In this role, you will provide essential administrative, regulatory, and project tracking support, adapting to the evolving needs of our Clinical Operations Department. A strong background in maintaining the Trial Master File (TMF) is essential for success. Key Responsibilities: Organize and maintain clinical study documentation, including the Trial Master Study Files, ensuring readiness for internal and external audits, final reconciliation, and proper archival. Handle the preparation, distribution, filing, and archiving of clinical documentation and reports in accordance with established standard operating procedures. Assist Clinical Research Associates (CRAs) and clinical teams in accurately updating and filing clinical documents from study visits while maintaining compliance and performance tracking systems. Conduct periodic reviews of study files to ensure completeness and audit readiness. Support the Study Manager in preparing, handling, and distributing Clinical Trial Supplies, along with maintaining tracking information. Assist in tracking and managing study trial data, queries, and overall clinical data flow. Provide general administrative support to the Clinical Operations Department and Study Manager(s) as required. Coordinate the ordering, dispatch, and tracking of trial materials such as source documents, diary cards, and lab/drug supplies. Communicate with clinical sites for specific requests, including enrollment updates, missing documentation, and meeting arrangements. Assist in tracking and distributing safety reports as needed. Coordinate document translation when required. Participate in clinical team meetings and generate meeting minutes. Help create PowerPoint presentations, including graphics, for project, departmental, sponsor, or business development purposes. Act as a central point of contact for project communications, correspondence, and documentation within the clinical team. Factors for Success: To excel in this role, candidates must demonstrate the ability to effectively manage the essential duties listed above. The following qualifications are key to success:

Join M3 USA as a Clinical Research Coordinator, where you will play a vital role in managing clinical trials and ensuring adherence to protocols. You will collaborate with researchers and participants to facilitate smooth operations and data collection throughout the study lifecycle.

Job SummaryWe are seeking a highly skilled Senior Systems Administrator to take on a pivotal role within our technical team at Megazone. This position focuses on managing and executing complex data center projects, requiring a deep understanding of client environments and the ability to work collaboratively with technical teams. The successful candidate will possess extensive hands-on experience with VMware, Windows, and Linux server environments, as well as expertise in storage systems and physical data center operations. The ideal applicant will demonstrate a proactive approach to problem-solving and possess strong communication skills to effectively engage with both client stakeholders and our internal cloud migration teams.Key ResponsibilitiesData Center Project Execution & Client Collaboration:Lead the technical execution of data center infrastructure projects independently from inception through to successful completion.Collaborate closely with client data center teams, including systems, network, and security administrators, to ensure a thorough understanding of their environments and requirements.Work in partnership with internal cloud migration teams to facilitate hybrid initiatives and data center exit strategies.VMware Infrastructure Management:Design, implement, and maintain the on-premise VMware vSphere infrastructure, focusing on ESXi hosts, vCenter Server, vSAN, and related virtualization components.Enhance the virtual environment for optimal performance, availability, and scalability.Manage vMotion and storage migration tasks, including hardware refreshes within the data center.Server & Systems Administration:Oversee a mixed Windows and Linux server environment, ensuring high levels of availability and robust security.Administer Windows Server infrastructure, including Active Directory, Group Policy, DNS, and DHCP.Conduct patching, upgrades, and maintenance for both Windows and Linux operating systems.Storage and Data Center Operations:Manage storage infrastructure, including SAN, physically attached storage, and object storage, ensuring data integrity and availability for virtualized environments.Physically engage in data center operations to rack, stack, and cable servers, storage, and networking equipment.

Join Artech Information Systems LLC as a Data Quality Assurance Analyst and play a crucial role in ensuring the integrity and accuracy of our data systems. In this dynamic position, you will work closely with cross-functional teams to develop and implement quality assurance protocols, identify data inconsistencies, and enhance data management processes.Your analytical skills and attention to detail will be vital in monitoring data quality metrics, documenting findings, and driving continuous improvement initiatives.

Hello, Tarsan!We appreciate your interest in the Clinical Trial Assistant position at itcss. If you believe this role aligns with your career aspirations, please reach out to your manager and HR Business Partner to discuss how your skills and experience match the requirements. If all goes well, we encourage you to submit your application, and our Talent Acquisition team will reach out to schedule an interview, allowing us to learn more about you.- Your Human Resources TeamAbout the RoleAs a Clinical Trial Assistant (CTA), you will play a vital role in ensuring the efficient execution of clinical research studies. This involves providing administrative, regulatory, and project tracking support. You will be assigned projects based on the evolving needs of the Clinical Operations Department, and prior experience with Trial Master File (TMF) maintenance is essential.Key Responsibilities:Organize and maintain clinical study documentation, including preparation for internal and external audits, final reconciliation, and archival.Manage the preparation, handling, distribution, filing, and archiving of clinical documentation and reports in accordance with standard operating procedures.Support Clinical Research Associates (CRAs) and clinical teams by accurately updating and filing clinical documents from study visits and updating compliance tracking systems.Conduct periodic reviews of study files to ensure completeness and audit readiness.Assist the Study Manager with the preparation and distribution of Clinical Trial Supplies and maintain tracking information.Help track and manage study trial data, queries, and clinical data flow.Provide general administrative support to the Clinical Operations Department and Study Manager(s) as needed.Coordinate the ordering and tracking of trial materials such as source documents, diary cards, lab supplies, and drug supplies.Communicate with clinical sites for specific requests, including enrollment updates and meeting arrangements.Assist in tracking and distributing safety reports.Coordinate document translation when necessary.Attend clinical team meetings and generate meeting minutes.Assist in creating PowerPoint presentations, including graphics, for projects, departmental updates, sponsor meetings, and business development.

Balt develops medical devices for neurovascular and peripheral vascular care. With over 45 years of experience, the company collaborates with healthcare professionals and institutions worldwide. Since introducing one of the first neurovascular intervention devices in 1977, Balt has grown to 13 offices in 11 countries and continues to expand its portfolio for stroke and vascular conditions. The team is dedicated to improving the lives of more than 150,000 patients by 2026 through ongoing innovation and collaboration. What sets Balt apart Work that directly affects patient outcomes A close-knit team united by a shared mission and strong values A culture built on recognition, respect, and diversity Comprehensive support for employees in all locations Role overview The Clinical Scientist position is based in Irvine, California. This role centers on clinical research and medical writing to advance Balt’s research goals. Key responsibilities include developing clinical investigation protocols (CIPs), preparing clinical study reports (CSRs), and supporting research and development activities. The Clinical Scientist leads clinical trials from First-in-Man (FIM) through pivotal and post-market phases. Additional duties involve authoring and reviewing scientific documents and providing leadership within the clinical department.

About Us:TP-Link Systems Inc., headquartered in the United States, stands as a global leader in providing reliable networking devices and innovative smart home products. Consistently recognized as the world's top supplier of Wi-Fi devices, TP-Link is dedicated to enhancing lives through advanced connectivity solutions. With a presence in over 170 countries, we are committed to continuous growth and excellence in service delivery.We believe that technology can transform the world for the better! At TP-Link Systems Inc., our mission is to develop dependable, high-performance products that connect users globally to the marvels of technology.With a focus on professionalism, innovation, excellence, and simplicity, our goal is to empower clients to achieve outstanding global performance while enabling consumers to experience a seamless and effortless lifestyle.Overview:We are on the lookout for an experienced Director of Embedded Software Systems to join our Enterprise Engineering Department and lead our embedded software development team. The ideal candidate will possess a robust technical foundation in embedded systems, demonstrate proven leadership abilities, and have a track record of delivering high-quality embedded software solutions. This strategic role demands a vision to drive innovation, optimize system performance, and ensure flawless integration of embedded software in our product offerings.

About the Role The Director of Early Development in Clinical Science will be responsible for developing comprehensive early-stage clinical plans, including program outlines, study designs, and essential clinical documents. This individual will lead cross-functional Study Teams to ensure the successful achievement of study milestones and will represent clinical development during core team and investigator meetings. This position requires close collaboration with various teams such as Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Finance, and Legal to facilitate efficient and scientifically sound early development clinical initiatives. Key Responsibilities: Own early development clinical deliverables, contributing to protocol development, document authoring, data analysis, and execution decisions to guarantee scientific rigor and operational excellence. Develop clinical plans, including timelines, budgets, and oversight of clinical teams. Draft and critically evaluate key clinical and regulatory documents (protocols, SAPs, CSRs, IBs, clinical value dossiers) to ensure scientific integrity and regulatory compliance. Lead training sessions for study investigators on protocols and clinical trial procedures. Conduct research to create foundational educational materials that guide early development program strategies. Analyze clinical data to support data-driven decision-making. Act as the program lead in early development core teams, investigator meetings, and scientific advisory boards. Engage effectively with internal and external stakeholders, including key opinion leaders (KOLs) and regulatory bodies. Demonstrate and promote essential leadership skills, including innovation, business acumen, results orientation, and a commitment to developing team capabilities. Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs, and other teams to ensure robust trial design and execution.

Dear Candidate,We appreciate your interest in the Vice President of Early Development - Clinical Science position. If you believe this opportunity aligns with your professional aspirations, we encourage you to discuss your qualifications with your current manager and HR Business Partner. Should everything align, please submit your application, and our Talent Acquisition team will reach out to schedule an interview to learn more about you.- Your Human Resources TeamAbout the RoleThe Vice President of Early Development - Clinical Sciences will deliver strategic and scientific leadership for early-stage clinical programs, managing trial direction, design, execution, and data interpretation from first-in-human studies through proof-of-concept and beyond. This role emphasizes the creation of a flexible early development clinical strategy to facilitate innovative trials, requiring creative and forward-thinking approaches to study design, endpoints, and operational strategies. This leader will challenge existing paradigms, employing rigorous scientific judgment and innovative thinking to inform critical development decisions.This position will collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Translational Sciences, Medical Affairs, Finance, and Legal to ensure efficient and scientifically sound early development clinical work. Additionally, this individual will partner closely with the Business Development team and partake in clinical due diligence.Key Responsibilities:Maintain an active, hands-on role in clinical strategy and execution, directly contributing to protocol development, study design decisions, data interpretation, and cross-functional problem-solving to swiftly and accurately assess proof-of-concept in early trials.Provide leadership and strategic oversight in defining study strategies, objectives, scope, and timelines to meet business needs, ensuring alignment among team priorities and initiatives.Keep the leadership team informed of study progress and escalate critical issues within the organization as necessary.Exhibit and promote key leadership competencies, including an innovative mindset, strong business acumen, a results-oriented approach, and a commitment to enhancing the capabilities and capacity of the team.Drive innovation by identifying and integrating cutting-edge technologies and methodologies into early development clinical trial designs.Shape clinical plans, including timelines, budgets, and resource allocations.

Balt develops advanced medical devices that support physicians in treating neurovascular and peripheral vascular conditions. With a history dating back to 1977, the company introduced one of the first neurovascular intervention devices and has steadily expanded its portfolio for stroke treatment and related therapies. Headquartered in Irvine, California, Balt collaborates with healthcare professionals and institutions worldwide. Its products are used by physicians across the globe, supported by 13 offices in 11 countries. The team at Balt shares a mission to improve patient outcomes and aims to impact 150,000 lives by 2026. The company values teamwork and the shared accomplishments that help physicians save lives.

We are seeking a dedicated and innovative Integrated Health Management System Lead to join our dynamic team at dev2. In this key position, you will spearhead the development and implementation of integrated health management systems that enhance patient care and operational efficiency. Your expertise will be crucial in aligning technology solutions with healthcare standards and regulations.

About UsFluxergy is a pioneering in vitro diagnostics firm at the forefront of laboratory testing innovation. We are proud to be developing the world's first multi-modal point-of-care platform that integrates molecular, clinical chemistry, immunoassay, and hematology testing into a unified system.Our cutting-edge platform serves various sectors, including clinical, veterinary, and food safety industries. We are on the lookout for self-driven problem solvers eager to revolutionize traditional laboratory infrastructures.At Fluxergy, our core identity is rooted in engineering excellence. We value critical thinking and pragmatic problem-solving, approaching challenges from a modular and systemic perspective. Transparent communication, adaptability to dynamic scenarios, and a willingness to explore new frontiers are integral to our collective success.To learn more about our product, visit: https://vimeo.com/176673475About the RoleWe are seeking an IT Systems Administrator who is poised to operate at an advanced technical level while maintaining close engagement with real-world support and systems. This role is ideal for candidates who have transitioned from traditional IT support to systems administration and infrastructure management.In this role, you will spearhead complex technical projects, enhance security and reliability across our systems, and influence the scalability of our IT infrastructure as the company expands. Working within a collaborative team environment, you will have the opportunity to significantly impact Fluxergy's IT landscape, serving as the primary expert for the support team and providing mentorship and strategic guidance on critical issues and projects.Team Culture:- Positive- Proactive- Accountable- Team-oriented

Join Sonsoft Inc. as an Informatica Master Data Management (MDM) Specialist. You will be part of a vibrant team dedicated to delivering high-quality data solutions that drive business success. This role is ideal for professionals looking to grow their expertise in data management and contribute to impactful projects.

Rivian and Volkswagen Group Technologies combine expertise from two leading automotive innovators to shape the next generation of software-defined vehicles. The collaboration centers on operating systems, zonal controllers, and cloud connectivity, tackling the evolving challenges of electric vehicles. Efforts span connectivity, artificial intelligence, and security, all aimed at building a smarter, more sustainable automotive future. Role overview The Senior Technical Program Manager - Systems Testing & Integration will coordinate the integration and testing of body controls, mobile app vehicle features, and cross-functional vehicle functionalities. This position plays a central role in aligning teams and ensuring successful software delivery for new vehicles and ongoing over-the-air updates. The work is based in Irvine, California. What you will do Track deliverables and milestones for requirements, architecture, and integration of features such as Pet Comfort, Camping, and Car Wash Mode. Oversee integration and testing of Body Controls features, including how the mobile app connects with vehicle systems. Collaborate with cross-functional teams to scope and plan deliverables across multiple vehicle programs, keeping the Test and Integration team on track. Work with technical leads to prioritize bugs and features for each release, considering technical risk, complexity, and delivery timelines. Provide regular updates on release progress and challenges to program teams and executive management, ensuring clear and timely communication. Escalate issues if deliverables risk missing deadlines and implement strategies to mitigate these risks. Identify and resolve release blockers and risks to maintain schedules and uphold software quality standards. Look for opportunities to improve processes and efficiency, implementing changes based on stakeholder feedback.