Clinical Data Management Lead

3 days ago


Aliso Viejo, California, United States Katalyst Healthcares and Life Sciences Full time

**Job Description:**

We are seeking an experienced Clinical Data Management Lead to join our team at Katalyst Healthcares and Life Sciences. In this role, you will oversee data management activities from study start-up to close-out, ensuring the quality and timeliness of data from service providers.

Key Responsibilities:

  • Represent Data Management in study team meetings, providing metrics and guidance on data-related issues.
  • Develop and manage study timelines, including Data Management Plans, Data Review Guidelines, and eCRF Completion Guidelines.
  • Prepare training materials for Investigator Meetings, internal teams, and site staff.
  • Maintain all Data Management project documentation in an audit-ready manner.
  • Support Lead Clinical Programmers in developing and managing Data Transfer Agreements.
  • Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed.
  • Reconcile data from external sources.
  • Assist in creating CRF and Edit Check Specifications.
  • User Acceptance Testing (UAT) of clinical databases, including EDC systems.
  • Manage EDC User Access for all assigned studies.
  • Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved.

Requirements:

  • Bachelor's degree or higher in biological science, nursing, or a related health field preferred.
  • Minimum of 7 years of experience in clinical data management, preferably within the pharmaceutical or medical device industry.
  • Strong understanding of clinical trial processes, FDA/ICH guidelines, and Good Clinical Data Management Practices (GCDMP).
  • Hands-on experience with Electronic Data Capture (EDC) systems such as MedNet, Rave, and Veeva Vault EDC.
  • Proficiency in data review and use of reporting/analytics tools.
  • Excellent project management and documentation skills, with experience writing Data Management Plans, Data Review Guidelines, and study timelines.
  • Strong verbal and written communication skills.
  • Ability to manage multiple clinical studies and tasks simultaneously.
  • Knowledge of CDISC Standards (CDASH, SDTM).
  • Problem-solving skills and flexibility in responding to business needs.
  • Ability to identify and mitigate risks to data quality proactively.
  • Experience in ophthalmology therapeutic areas.
  • Familiarity with Case Report Form and Edit Check Specification development.

Benefits:

  • Competitive salary: $85,000 - $115,000 per year
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment


  • Aliso Viejo, California, United States MicroVention Full time

    Job OverviewWe are seeking an experienced Clinical Data Management Leader to oversee clinical data management activities across multiple studies from start-up through closure.Responsibilities:Prioritize projects in support of corporate goals and objectivesDevelop and/or enhance data management processes to ensure complete, accurate, high-quality clinical...


  • Aliso Viejo, California, United States Eastridge Full time

    We are seeking a seasoned Senior Clinical Data Manager to join our team at Eastridge Workforce Solutions, dedicated to connecting skilled professionals with meaningful opportunities. This role offers an exciting opportunity to contribute to the development of innovative products in the ophthalmic market while ensuring data integrity and compliance with...


  • Aliso Viejo, California, United States MicroVention Full time

    Company Overview: MicroVention is a leading provider of medical devices. We are seeking an experienced professional to lead our global clinical education initiatives.Job Description: This role involves supporting and leading the management of Professional Affairs and Clinical Education initiatives and programs to maintain and expand the worldwide adoption of...


  • Aliso Viejo, California, United States Spyglass Pharma Full time

    Unlock Career Advancement OpportunitiesWe are seeking a seasoned Clinical Research Associate (CRA) Manager to lead our team at SpyGlass Pharma.About the RoleThis senior-level position ensures that clinical trials are conducted in compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and applicable standard operating procedures...


  • Aliso Viejo, California, United States Genpact Full time

    Company Overview: Genpact is a global professional services firm that delivers outcomes shaping the future. With 125,000+ people across 30+ countries, our innate curiosity and entrepreneurial agility drive us to create lasting value for clients.About the Role:We are inviting applications for the role of Data Engineering Lead - Database Specialist. In this...


  • Aliso Viejo, California, United States Terumo Neuro Full time

    About the RoleIn this critical position at Terumo Neuro, you will lead Master Data Governance efforts, ensuring data integrity and compliance across our ERP system and other applications.Main Responsibilities:Manage core Master Data objects to guarantee data accuracy and consistency.Perform regular data audits, validation, and cleansing to maintain master...


  • Aliso Viejo, California, United States NeoGenomics Laboratories Full time

    Are you a motivated leader seeking a dynamic opportunity to drive operational excellence in a clinical laboratory setting?Negotiable salary: $90,000 - $120,000 per year.We are NeoGenomics Laboratories, a leading cancer reference laboratory dedicated to improving patient care through exceptional work. Our mission is purpose-driven, and we promise to provide...


  • Aliso Viejo, California, United States Pacific Companies, Inc. Full time

    Are you a skilled medical professional looking to take on a leadership role in pain management? Pacific Companies, Inc. is seeking an experienced Medical Director for our Telemedicine Pain Management Clinic in North Carolina.About the RoleWe are looking for a board-certified Family Medicine physician to supervise two Nurse Practitioners who provide direct...


  • Aliso Viejo, California, United States MicroVention Full time

    Job OverviewWe are seeking a highly skilled Vascular Therapies Project Manager to join our team at MicroVention.Salary: $120,000 - $180,000 per yearAbout the RoleThe successful candidate will be responsible for leading and managing professional affairs and clinical education initiatives, including proctoring programs, clinical immersion programs, and...

  • Genetics Team Lead

    1 week ago


    Aliso Viejo, California, United States Ambry Genetics Full time

    Job OverviewA dynamic opportunity has emerged at Ambry Genetics, a pioneering molecular genetics laboratory in Aliso Viejo, California. As an Assistant Laboratory Director, you will play a pivotal role in shaping the future of genetic testing and diagnostics.About UsAmbry Genetics is a trailblazing company that seeks to revolutionize healthcare by harnessing...


  • Aliso Viejo, California, United States Pacific Companies, Inc. Full time

    We are a reputable locum tenens and permanent recruiting firm, dedicated to providing exceptional healthcare solutions. Our team is seeking a highly skilled Medical Director to join our Internal Medicine Clinic in Michigan.As a Medical Director, you will be responsible for leading our team of healthcare professionals, ensuring the highest quality patient...


  • Aliso Viejo, California, United States Pacific Companies, Inc. Full time

    About Our OpportunityJoin Pacific Companies, Inc. as a Lead Physician in our state-of-the-art medical facility located in the heart of Nebraska.Competitive Salary and BenefitsWe offer an attractive salary range of $250,000 - $350,000 per year, depending on experience, along with a comprehensive benefits package that includes full malpractice coverage, paid...


  • Aliso Viejo, California, United States StubHub Full time

    Unlock Your Potential as a Senior Software Engineer at StubHubAbout UsAt StubHub, we're on a mission to redefine the live event experience on a global scale. As a leading marketplace for buying and selling tickets, we're committed to providing a safe, convenient, and enjoyable experience for our customers.The OpportunityWe're seeking an experienced Senior...


  • Aliso Viejo, California, United States Pacific Companies, Inc. Full time

    Job Title: Clinical Mental Health SpecialistWe are seeking a highly skilled Clinical Mental Health Specialist with expertise in treating eating disorder and/or mood and anxiety disorder patients.About the Role:Conduct comprehensive psychiatric evaluations, diagnose, and develop tailored treatment plans for patients with various mental health...


  • Aliso Viejo, California, United States Pacific Companies, Inc. Full time

    About the OpportunityWe are seeking a skilled Physician to join our team at a mens health clinic in Southern California. As a valued member of our medical staff, you will be responsible for conducting history and physical intakes for patients with erectile dysfunction.Job DetailsLocation: 40 miles from Downtown Los AngelesSchedule: Flexible, any two days per...


  • Aliso Viejo, California, United States MicroVention Full time

    Job Description:Job Title: Veeva Vault Systems AdministratorCompany: MicroVentionKey Responsibilities:Perform day-to-day administration activities of Veeva Vault as per approved procedures.Oversight of managed services to ensure that application configuration meets business requirements and is consistent with MicroVention standards.Accountable for...


  • Aliso Viejo, California, United States Cumming Group Full time

    Company OverviewCumming Group is a dynamic project and cost management consultancy, ranked among the top 20 in ENR. With over 50 offices globally, we offer diverse projects and double-digit year-over-year revenue growth opportunities.Estimated Salary: $140,000 - $180,000 per yearJob DescriptionWe are seeking an experienced Planning and Design Manager to work...

  • Cloud Gaming Expert

    1 week ago


    Aliso Viejo, California, United States PlayStation Global Full time

    PlayStation Global is a leading entertainment company that produces innovative products and services. We're currently seeking a highly skilled Senior Service Reliability Engineer to join our team.We offer an estimated base pay range of $172,100-$258,100 USD, along with a comprehensive benefits package including medical, dental, vision, matching 401(k), paid...


  • Aliso Viejo, California, United States KinderCare Education Full time

    Job DescriptionWe are seeking a detail-oriented and organized Education Support Specialist to join our team at KinderCare Education. As an integral part of our staff, you will play a crucial role in supporting our educational programs.Key ResponsibilitiesData entry and record-keeping: You will be responsible for accurately entering data into our system and...


  • Aliso Viejo, California, United States Providence Full time

    Care Management Opportunity">We are seeking a dedicated Nurse Care Manager to join our team at St. Joseph Hospital-Orange in Orange, CA.">About the Role:">The Nurse Care Manager will be responsible for providing comprehensive care management services to patients, families, and healthcare providers. This includes assessing patient needs, developing...