8 Manager, Clinical Data Management Jobs in Irvine, CA
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Manager, Clinical Data Management
$123k-149k (estimate)
Full Time | Medical Technology
2 Weeks Ago
JenaValve Technology, Inc. is Hiring a Manager, Clinical Data Management Near Irvine, CA
Job DetailsJob Location
Irvine, CA
Position Type
Full Time
Education Level
4 Year Degree
Salary Range
$145,000.00 - $150,000.00 Salary/year
Description Job Title : Manager, Clinical Data Management
Supervisor/Manager Title: Director, Clinical Affairs
Job Description Summary: The Clinical Data Management Manager contributes to the overall conduct and timely execution of JenaValve clinical trials by overseeing clinical database (design & validate, maintain and shutdown EDC) for clinical trials and overseeing data quality related appropriate clinical databases, and participating in the review and analysis of clinical data. The candidate closely collaborates with other JenaValve cross-functional teams (Study Management, Field Monitoring, Regulatory Affairs, Safety, etc.) in achieving corporate objectives. The role will ensure the quality and integrity of data collected in clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues.
Job Responsibilities:
Irvine, CA
Position Type
Full Time
Education Level
4 Year Degree
Salary Range
$145,000.00 - $150,000.00 Salary/year
Description Job Title : Manager, Clinical Data Management
Supervisor/Manager Title: Director, Clinical Affairs
Job Description Summary: The Clinical Data Management Manager contributes to the overall conduct and timely execution of JenaValve clinical trials by overseeing clinical database (design & validate, maintain and shutdown EDC) for clinical trials and overseeing data quality related appropriate clinical databases, and participating in the review and analysis of clinical data. The candidate closely collaborates with other JenaValve cross-functional teams (Study Management, Field Monitoring, Regulatory Affairs, Safety, etc.) in achieving corporate objectives. The role will ensure the quality and integrity of data collected in clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues.
Job Responsibilities:
- Oversee, manage, and execute the development of clinical database design and implementation for JenaValve clinical studies, including User Acceptance Testing (UAT), query logic and language, edit checks, roles, and permissions and CRF completion guidelines and requirements as needed for specific databases.
- Collaborate with Clinical and Medical Affairs personnel and other appropriate stakeholders such as Study Management team to develop Data Management Plans and Data Surveillance Plans (as applicable) for clinical studies.
- Develop EDC training materials and documentation.
- Be responsible for data analysis with Study Management and statistical experts and consultants.
- Manage timelines and milestones associated with database design, data review, and database locks/freezes with internal resources and/or external vendors.
- Oversee the overall quality of data and proactively identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns to key deliverables.
- Work closely with the Study Management team, including study managers, clinical field monitors to ensure quality of clinical data through appropriate data collection and review.
- Develop and manage data management quality documentation including Department Standard Operating Procedures (DSOPs) and Work Instructions (WIs) as needed.
- Prepare and support vendor and agency audits as assigned.
- Hire and manage clinical data team members as needed.
- 8 years of increasing experience in clinical data management phases is required (preferred in medical devices).
- Technical skills in clinical databases and reporting tools (e.g. Castor, Medidata Rave, Oracle EDC) is preferred.
- B.S. or B.A. in biological or medical/clinical sciences preferred with 5 years functioning as a lead data manager. Advanced degree is preferred.
- Working knowledge of GCPs, Clinical Quality and Compliance and Regulatory requirements related to clinical research.
- Working knowledge of data management practices.
- Strong organization skills and time management in a dynamic environment; ability to work on multiple projects.
- Good critical thinking and sound communication skills.
- Self-motivated and detailed oriented.
- Knowledge of GCP governing the conduct of clinical trials; working knowledge of Medical Device regulations and ICH Guidelines.
- Demonstrated experience working with all phases of study conduct: start-up, maintenance, and closeout.
- Experience with driving activities for interim and final database locks for regulatory submissions, publications, and podium presentations, and clinical trial data audits.
- Experience writing SOPs and work instructions.
- Must have ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.
- Excellent oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
- Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$123k-149k (estimate)
POST DATE
06/09/2024
EXPIRATION DATE
07/07/2024
WEBSITE
jenavalve.com
HEADQUARTERS
MUNCHEN, BAYERN
SIZE
50 - 100
FOUNDED
2013
CEO
PETER CHRISTIAAN WULFF
REVENUE
$10M - $50M
INDUSTRY
Medical Technology
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The job skills required for Manager, Clinical Data Management include Data Management, Clinical Data Management, Clinical Trial, Project Management, Analysis, Database Design, etc. Having related job skills and expertise will give you an advantage when applying to be a Manager, Clinical Data Management. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manager, Clinical Data Management. Select any job title you are interested in and start to search job requirements.
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