Clinical Data Manager

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.

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.

Role Overview AbbVie is seeking a Clinical Data Systems Manager in Irvine. This position manages the development and maintenance of clinical data systems that support research and development projects. The role ensures these systems meet standards for data integrity, compliance, and performance. Key Responsibilities Oversee the design, implementation, and management of clinical data systems. Work closely with teams across functions to support research goals. Monitor system performance and address issues to maintain reliability. Help ensure data quality and compliance with regulatory requirements. About AbbVie AbbVie is a global biopharmaceutical company focused on research and innovation in healthcare.

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.

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 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.

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.

About the Position The Vice President of Early Development - Clinical Science plays a pivotal role in shaping the strategic and scientific direction of early development clinical programs. This leadership position entails overseeing the design, execution, and data interpretation of clinical trials from first-in-human studies through proof-of-concept. The primary objective is to develop a versatile early clinical development strategy that fosters innovative trial designs, endpoints, and operational tactics. This leader is expected to challenge traditional methods, leveraging robust scientific judgment and creative thinking to guide critical development decisions. This role will require collaboration across multiple functions, including Clinical Operations, Regulatory Affairs, Translational Sciences, Medical Affairs, Finance, and Legal, to ensure the efficient and scientifically sound execution of early development initiatives. Additionally, the VP will partner with the Business Development team and engage in clinical due diligence activities. Key Responsibilities: Actively contribute to clinical strategy and execution, including protocol development, study design, data interpretation, and problem-solving to quickly assess proof-of-concept in early trials. Provide leadership and strategic oversight in study strategy, objectives, scope, and timelines to align the team with common priorities and business needs. Keep the leadership team updated on study progress and escalate critical issues as necessary. Foster a culture of innovation, strong business acumen, and a commitment to team development and capability expansion. Incorporate advanced technologies and methodologies into early clinical trial designs. Develop clinical plans, including timelines and budgets, while overseeing clinical teams. Represent the company in interactions with investigators, regulators, and executive stakeholders. Generate insights that support safe usage, patient targeting, and clinical/commercial positioning. Analyze clinical data from early to mid-stage studies. Contribute as a senior leader within the broader leadership team, influencing strategic decisions. Collaborate with Clinical Operations, Regulatory Affairs, and Translational Sciences to drive clinical advancements.

Role overview The Associate Director, Aesthetics Clinical Development at AbbVie Inc. in Irvine provides leadership for clinical research projects in the aesthetics space. This position shapes product development strategies and ensures that regulatory standards are met at every stage. What you will do Direct clinical research initiatives for aesthetic products, guiding studies from concept through execution. Establish strategic priorities for development programs and maintain compliance with regulatory requirements. Refine research methodologies to promote reliable, high-quality outcomes. Collaborate with cross-functional teams to improve patient outcomes and contribute to advancements in aesthetic medicine.

Welcome to the opportunity of a lifetime!We appreciate your interest in this role. Please review the details, and if you believe this aligns with your career aspirations, we encourage you to discuss your qualifications with your current manager and HR Business Partner. If you're ready to move forward, apply now, and our Talent Acquisition team will reach out for an interview to get to know you better.- Your Human Resources TeamAbout the RoleThe Director of Early Development in Clinical Science will be instrumental in crafting early development clinical strategies, outlining programs, designing studies, and creating essential clinical documentation. You will take charge of leading cross-functional study teams to achieve study objectives and represent clinical development in key core team and investigator meetings as required.This position demands close collaboration with various teams, including Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Finance, and Legal, to facilitate effective and scientifically sound early development clinical operations.Key Responsibilities:Take ownership of early development clinical deliverables by actively contributing to protocol development, document creation, data analysis, and decision-making to ensure both scientific integrity and operational excellence.Develop clinical plans that encompass timelines, budgets, and team supervision.Create and critically assess key clinical and regulatory documents, ensuring adherence to scientific rigor and regulatory compliance.Lead and train study investigators on protocol and clinical trial procedures.Research and develop foundational educational materials to support early development program strategies.Analyze clinical data to support evidence-based decision-making.Act as the program lead in early development core teams, investigator meetings, and scientific advisory boards.Engage with internal and external stakeholders, including key opinion leaders (KOLs) and regulatory bodies.Demonstrate and promote essential leadership qualities, including innovative thinking, strong business insight, results-oriented focus, and a commitment to enhancing team capabilities.Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs, and other departments to ensure robust trial design and scientific rigor.

Join AbbVie as an Associate Director of Aesthetics Clinical Development, where you will lead innovative clinical trials and contribute to advancing our aesthetic offerings. In this pivotal role, you will collaborate with cross-functional teams to design and execute clinical strategies that align with AbbVie's commitment to providing high-quality aesthetic solutions.

AbbVie is seeking a passionate and innovative Associate Director of Aesthetics Clinical Development to lead our clinical initiatives in the aesthetics sector. This pivotal role involves overseeing clinical trials, collaborating with cross-functional teams, and driving strategic advancements in our aesthetic product pipeline. The ideal candidate will have a strong background in clinical development, exceptional leadership skills, and a commitment to enhancing patient outcomes.

Join CompassX, a prestigious boutique consulting firm specializing in business and technology solutions for Fortune 500 and high-growth clients. We drive transformative initiatives across industries such as financial services, pharmaceuticals, aerospace, consumer products, and quick service restaurants.With over 15 years of excellence, CompassX has earned accolades including being a three-time winner of Consulting Magazine’s Best Boutique Firms to Work For, alongside recognitions as a “Best Place to Work” in Southern California and one of INC.’s 5000 fastest-growing private companies in the U.S.We are seeking a Solution Owner (Data, Technology & AI) who will serve as a crucial link between executive strategy and technical execution for our enterprise clients. You will act as the single source of truth, ensuring that complex Data and AI projects are executed with clarity, stability, and measurable business impact. This role is perfect for someone skilled in Agile program management and product strategy, adept at navigating multiple roles including The Translator, The Navigator, The Therapist, and The Air Traffic Controller to guide engineering teams from initial discovery to production in fast-paced development environments.This position is fully remote; however, we are currently hiring only in the following states: California, Washington, Texas, Oregon, Colorado, Pennsylvania, and Georgia.