IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Clinical Data Management Manager

Company: Hydrogen Group
Location: Irvine
Posted on: September 15, 2020

Job Description:

Duties & Responsibilities: -- Lead all aspects of clinical data management for all concurrent projects from clinical study start-up to conduct and study closeout. Act as a consultant in data management processes and principles for all projects and other functional groups (20%) Define and lead project management activities for multiple complex projects to bring clinical studies on-line Provide training, mentorship and guidance to other clinical data managers and/or cross-functional members. (15%) Lead the data cleaning plan according to DMP (Data Management Plan), SOPs and associated documents, for assigned studies/projects, using the clinical data management system, listings, and reports. (10%) Responsible for data management milestones and deliverables and ensure that quality standards are met on assigned projects within the department. Define, develop and/or review creation of essential Data Management deliverables including data management plans (DMPs), data transfer specifications, eCRF Completion Guidelines, training materials, and user aids, etc. (10%) Identify and make recommendations on trends in data discrepancies and remediation, including developing instruments, and training requirements across studies and therapeutic areas to ensure uniformity in approach and execution. (10%) Provide data management solutions/guidance and risk mitigation approaches to project teams for operational issues through the use of available data, tools, feedback and discussions (10%) Review, create, maintain, and implement SOPs, work instructions, process improvement initiatives, best practice, lesson learned and other general workflow optimization with respect to data management function to ensure compliance, accuracy, and efficiency across functional areas (5%) Manage CDM related requests from external stakeholders (e.g., regulators, notified bodies, non-governmental agencies, core labs, independent study committee, and auditors) (5%) Collaborate with vendors and internal teams to define and develop integration (data & process) specifications for clinical trial database. (5%) Review clinical protocols to ensure data requirements are sufficient to support study purpose and study endpoints. (5%) 10. Oversee the build of statistical and data management file infrastructure. Work with Biostatistician to program and verify statistical analysis programs. Lead the implementation of project documentation per Edward's procedures. Collaborate with biostatistician to develop and finalize SAP and respond to statistical analysis considerations. Perform audits of biostatistical and data management documentation and file directory. Oversee the compilation of statistical analysis documentation for regulatory submissions. -- Required Skills: SME on Data management SME on use and creation of data management documentation Leadership- Lead group with questions and projects up and running Proficiency in SAS Education: Bachelor's Degree or equivalent in related field with 10 years of previous related experience in clinical research including clinical data management Required or Master's Degree or equivalent in related field with 8 years of previous related experience in clinical research including clinical data management Required and Experience with EDC (Electronic Data Capture) systems and software testing in a clinical research or clinical data management environment Required and Experience authoring DMPs, SOPs, and training materials Required Skills and training materials. -- Additional Required Skills: -- Documentation Biostatistics Project Management Process Improvement Clinical Data Management Additional Skills: Clinical Trial Data Management Integration Mitigation Optimization Remediation Software Testing Sops Therapeutic Training Workflow Clinical Studies Clinical Study Data Cleaning Databases Integrator SME Subject Matter Expert

Keywords: Hydrogen Group, Irvine , Clinical Data Management Manager, Healthcare , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Seasonal Travel RN Jobs - ICU, CVICU, SICU, MICU, NICU, PICU
Description: Travel Nurses Needed - All RN Specialties br Registered Nurses: Critical Care ICU, CVICU, SICU, MICU br Hospitals are posting their seasonal staffing needs br Would you like to spend the fall / (more...)
Company: HealthCare Travelers
Location: Yucaipa
Posted on: 09/25/2020

Travel Nurse Neonatal Intensive Care RN-NICU
Description: Travel Nurse Neonatal ICU RN Registered Nurse br NICU Travel Nurse Jobs Assignments br Looking for a NICU travel assignment You are in the right place, the HCEN Network of staffing agencies have (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020

Experienced Travel RNs - ICU, CVICU, SICU, MICU, NICU, PICU
Description: Travel Nurses Needed - All RN Specialties br Registered Nurses: Critical Care ICU, CVICU, SICU, MICU br Hospitals are posting their seasonal staffing needs br Would you like to spend the fall / (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020


RN CVOR / CVICU / Cath Lab (Seasonal Travel Nurse Jobs)
Description: Travel Nurses Needed - All RN Specialties br Registered Nurses: CathLab, CVOR CVICU Assignmnets br Hospitals are posting their seasonal staffing needs br Would you like to spend the fall / winter (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020

NICU RN Neonatal Travel Registered Nurse
Description: Travel Nurses Needed - Neonatal RN Specialties br Nationwide NICU Travel Nursing Jobs br Looking for a NICU RN travel assignment You are in the right place, the HCEN Network of staffing agencies (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020

Cath Lab Registered Nurse - Travel RN
Description: Travel Nurses Needed - Cardiac Services br Nationwide Travel Cath Lab RN Nursing Jobs br Looking for a Cardiac Cath Lab travel assignment You are in the right place, the HCEN Network of staffing (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020

ICU Burn Unit Registered Nurses, RN Travel
Description: Travel Nurses Needed - Intensive Care Burn Unit br Nationwide Trauma / Burn Intensive Care Unit Nursing JobsHCEN has numerous request for RN Candidate Profiles Looking for a Intensive Care Burn Unit (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020

Seasonal Travel Nurse Jobs - RN CVOR / CVICU / Cath Lab
Description: Travel Nurses Needed - All RN Specialties br Registered Nurses: CathLab, CVOR CVICU Assignmnets br Hospitals are posting their seasonal staffing needs br Would you like to spend the fall / winter (more...)
Company: HealthCare Travelers
Location: Yucaipa
Posted on: 09/25/2020

Travel RN Nurse Jobs - HealthCareTravelers.com
Description: Travel Nurses Needed - All RN Specialties br Nationwide Registered Nurse Travel Jobs br Looking for a RN travel assignment You are in the right place, the HCEN Network of staffing agencies have numerous (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020

RN Travel Nurse Surgical Intensive Care Unit (SICU)
Description: Travel Nurses Needed - SICU br Nationwide Surgical Intensive Care Unit Nursing JobsHCEN has numerous request for RN Candidate Profiles Looking for a Intensive Care Unit travel assignment You are in (more...)
Company: Travel RN Jobs
Location: Yucaipa
Posted on: 09/25/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds