Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: Sr.Clinical Data Manager.
United States Jobs Expertini

Urgent! Sr.Clinical Data Manager Job Opening In Irvine – Now Hiring Katalyst HealthCares & Life Sciences

Sr.Clinical Data Manager



Job description


Responsibilities:

  • Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.

  • Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities.

  • Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks.

  • Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities.

  • Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities.

  • Provide study level oversight and expertise for CDM activities for multiple studies.

  • Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns.

  • Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans.

  • Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards.

  • Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor.

  • Make decisions and chart courses through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area.

  • Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis.

  • Assist with routine quality audits as applicable.

  • Requirements:
  • Bachelor's Degree in scientific discipline (RN or advanced degree preferred).

  • years' industry experience in CDM in all study phases and activities from startup to archival with at least years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals.

  • Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred).

  • Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats
  • Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials.

  • Working knowledge of the MedDRA and WHO Drug dictionary coding terms Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manner.

  • Experience in implementing, validating, and administrating other clinical systems for data collection (, eSource, IVRS, IWRS, core lab web-based portals).

  • Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks.

  • Excellent verbal and written communication skills.



  • Required Skill Profession

    Mathematical Science Occupations



    Your Complete Job Search Toolkit

    ✨ Smart • Intelligent • Private • Secure

    Start Using Our Tools

    Join thousands of professionals who've advanced their careers with our platform

    Rate or Report This Job
    If you feel this job is inaccurate or spam kindly report to us using below form.
    Please Note: This is NOT a job application form.


      Unlock Your Sr Clinical Potential: Insight & Career Growth Guide


    • Real-time Sr Clinical Jobs Trends in Irvine, United States (Graphical Representation)

      Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Sr Clinical in Irvine, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 89910 jobs in United States and 377 jobs in Irvine. This comprehensive analysis highlights market share and opportunities for professionals in Sr Clinical roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

    • Are You Looking for Sr.Clinical Data Manager Job?

      Great news! is currently hiring and seeking a Sr.Clinical Data Manager to join their team. Feel free to download the job details.

      Wait no longer! Are you also interested in exploring similar jobs? Search now: .

    • The Work Culture

      An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Katalyst HealthCares & Life Sciences adheres to the cultural norms as outlined by Expertini.

      The fundamental ethical values are:
      • 1. Independence
      • 2. Loyalty
      • 3. Impartiality
      • 4. Integrity
      • 5. Accountability
      • 6. Respect for human rights
      • 7. Obeying United States laws and regulations
    • What Is the Average Salary Range for Sr.Clinical Data Manager Positions?

      The average salary range for a varies, but the pay scale is rated "Standard" in Irvine. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

    • What Are the Key Qualifications for Sr.Clinical Data Manager?

      Key qualifications for Sr.Clinical Data Manager typically include Mathematical Science Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

    • How Can I Improve My Chances of Getting Hired for Sr.Clinical Data Manager?

      To improve your chances of getting hired for Sr.Clinical Data Manager, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

    • Interview Tips for Sr.Clinical Data Manager Job Success
      Katalyst HealthCares & Life Sciences interview tips for Sr.Clinical Data Manager

      Here are some tips to help you prepare for and ace your job interview:

      Before the Interview:
      • Research: Learn about the Katalyst HealthCares & Life Sciences's mission, values, products, and the specific job requirements and get further information about
      • Other Openings
      • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
      • Dress Professionally: Choose attire appropriate for the company culture.
      • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
      • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
      During the Interview:
      • Be Punctual: Arrive on time to demonstrate professionalism and respect.
      • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
      • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
      • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
      • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
      • Follow Up: Send a thank-you email to the interviewer within 24 hours.
      Additional Tips:
      • Be Yourself: Let your personality shine through while maintaining professionalism.
      • Be Honest: Don't exaggerate your skills or experience.
      • Be Positive: Focus on your strengths and accomplishments.
      • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
      • Turn Off Phone: Avoid distractions during the interview.
      Final Thought:

      To prepare for your Sr.Clinical Data Manager interview at Katalyst HealthCares & Life Sciences, research the company, understand the job requirements, and practice common interview questions.

      Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Katalyst HealthCares & Life Sciences's products or services and be prepared to discuss how you can contribute to their success.

      By following these tips, you can increase your chances of making a positive impression and landing the job!

    • How to Set Up Job Alerts for Sr.Clinical Data Manager Positions

      Setting up job alerts for Sr.Clinical Data Manager is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!